Who else makes this device?

Name: Persona® Vivacit-E®
Brand: Persona® Vivacit-E®

Orthopedic › ProstheticProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Persona® Vivacit-E®

286 catalogue numbers from 42-5222-005-18, listed by Zimmer, Inc., United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 21 manufacturers in China are registered for this product code.

Registry build 21.09.26

21manufacturers in China registered for this device type

286catalogue numbers in this listing

51510(k) clearances naming this product code

40recalls on this code

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JWH
Manufacturer	City	Province	Registered as	Device types
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Guangzhou Aquila Precise Tools Limited	Guangzhou	Guangdong	Contract manufacturer	28
B-ONE Medical (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	23
LX Precision Shanghai Co Ltd	Shanghai	Shanghai	Contract manufacturer	19
Stryker (Suzhou) Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	10
b-ONE Medical (Beijing) Co., Ltd.	Beijing	Beijing	Contract manufacturer	7
Changzhou Wastonortho Medical Appliance Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	5

Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Record

Regulatory record for Persona® Vivacit-E®
Listed by	Zimmer, Inc., United States
FDA product code	JWH
Device type	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class	Class 2
Regulation	21 CFR 888.3560
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K121771
Record published	2015-09-17
Record revised	2022-03-23 (version 5)

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Sizes	Height 10 to 20 mm

Catalogue Numbers

Catalogue numbers for Persona® Vivacit-E®
Catalogue number	Size	Status
42-5222-005-18	Height 18 mm	In distribution
42-5222-001-10	Height 10 mm	In distribution
42-5221-002-10	Height 10 mm	In distribution
42-5124-001-14	Height 14 mm	In distribution
42-5226-007-18	Height 18 mm	In distribution
42-5121-008-20	Height 20 mm	In distribution
42-5121-001-14	Height 14 mm	In distribution
42-5126-011-14	Height 14 mm	In distribution
42-5126-003-13	Height 13 mm	In distribution
42-5224-009-11	Height 11 mm	In distribution
42-5124-008-10	Height 10 mm	In distribution
42-5124-002-12	Height 12 mm	In distribution
42-5221-004-10	CR Femur Sizes 6-7	In distribution
42-5121-001-16	Height 16 mm	In distribution
42-5121-010-16	Height 16 mm	In distribution
42-5226-001-16	Height 16 mm	In distribution
42-5126-002-11	Height 11 mm	In distribution
42-5121-005-10	Height 10 mm	In distribution
42-5124-007-13	Height 13 mm	In distribution
42-5121-001-13	Height 13 mm	In distribution
42-5226-004-14	Height 14 mm	In distribution
42-5121-007-20	CR Femur Sizes 6-7	In distribution
42-5226-009-16	Height 16 mm	In distribution
42-5120-005-14	Height 14 mm	In distribution
42-5224-010-20	Height 20 mm	In distribution
42-5121-006-20	Height 20 mm	In distribution
42-5121-011-12	Height 12 mm	In distribution
42-5126-011-20	Height 20 mm	In distribution
42-5121-006-13	CR Femur Sizes 4-5	In distribution
42-5221-003-12	Height 12 mm	In distribution
42-5121-009-13	Height 13 mm	In distribution
42-5221-003-13	Height 13 mm	In distribution
42-5402-000-38	38 mm, Diameter, 9.5 mm, Thickness	In distribution
42-5124-002-20	Height 20 mm	In distribution
42-5121-011-14	Height 14 mm	In distribution
42-5120-007-13	Height 13 mm	In distribution
42-5226-008-18	Height 18 mm	In distribution
42-5122-003-10	Height 10 mm	In distribution
42-5121-004-10	CR Femur Sizes 6-7	In distribution
42-5126-004-14	Height 14 mm	In distribution
42-5224-005-12	Height 12 mm	In distribution
42-5121-010-10	CR Femur Size 12	In distribution
42-5126-002-14	Height 14 mm	In distribution
42-5221-005-14	Height 14 mm	In distribution
42-5226-010-18	Height 18 mm	In distribution
42-5221-001-12	CR Femur Sizes 1-2	In distribution
42-5124-007-18	Height 18 mm	In distribution
42-5221-009-14	Height 14 mm	In distribution
42-5126-008-11	Height 11 mm	In distribution
42-5221-004-14	Height 14 mm	In distribution
42-5121-005-11	Height 11 mm	In distribution
42-5124-010-10	Height 10 mm	In distribution
42-5121-005-16	Height 16 mm	In distribution
42-5222-007-20	Height 20 mm	In distribution
42-5122-001-14	Height 14 mm	In distribution
42-5121-001-11	Height 11 mm	In distribution
42-5220-004-12	Height 12 mm	In distribution
42-5121-005-18	CR Femur Sizes 8-9	In distribution
42-5120-002-18	Height 18 mm	In distribution
42-5124-010-18	Height 18 mm	In distribution
42-5226-010-20	Height 20 mm	In distribution
42-5224-004-10	Height 10 mm	In distribution
42-5221-004-16	CR Femur Sizes 6-7	In distribution
42-5221-009-20	Height 20 mm	In distribution
42-5121-006-10	Height 10 mm	In distribution
42-5221-004-20	Height 20 mm	In distribution
42-5221-001-18	CR Femur Sizes 1-2	In distribution
42-5226-011-18	Height 18 mm	In distribution
42-5121-006-11	Height 11 mm	In distribution
42-5226-007-10	Height 10 mm	In distribution
42-5124-008-16	Height 16 mm	In distribution
42-5224-006-16	Height 16 mm	In distribution
42-5120-005-12	Height 12 mm	In distribution
42-5120-007-10	Height 10 mm	In distribution
42-5120-001-13	Height 13 mm	In distribution
42-5124-011-12	Height 12 mm	In distribution
42-5121-001-10	CR Femur Sizes 1-2	In distribution
42-5124-003-18	Height 18 mm	In distribution
42-5124-001-16	Height 16 mm	In distribution
42-5124-004-14	Height 14 mm	In distribution
42-5224-001-18	Height 18 mm	In distribution
42-5224-005-13	Height 13 mm	In distribution
42-5124-008-12	Height 12 mm	In distribution
42-5124-002-13	Height 13 mm	In distribution
42-5220-007-14	Height 14 mm	In distribution
42-5221-005-12	Height 12 mm	In distribution
42-5222-001-12	Height 12 mm	In distribution
42-5124-004-18	Height 18 mm	In distribution
42-5121-007-18	Height 18 mm	In distribution
42-5221-006-12	CR Femur Sizes 4-5	In distribution
42-5121-007-12	Height 12 mm	In distribution
42-5120-003-10	Height 10 mm	In distribution
42-5222-002-14	Height 14 mm	In distribution
42-5226-001-12	Height 12 mm	In distribution
42-5121-011-12	Height 12 mm	In distribution
42-5120-003-12	Height 12 mm	In distribution
42-5124-002-11	Height 11 mm	In distribution
42-5120-005-10	Height 10 mm	In distribution
42-5124-006-18	Height 18 mm	In distribution
42-5121-003-10	Height 10 mm	In distribution
42-5120-006-14	Height 14 mm	In distribution
42-5220-001-18	Height 18 mm	In distribution
42-5126-006-20	Height 20 mm	In distribution
42-5121-002-16	Height 16 mm	In distribution
42-5124-009-18	Height 18 mm	In distribution
42-5122-002-18	Height 18 mm	In distribution
42-5126-009-14	Height 14 mm	In distribution
42-5121-009-14	Height 14 mm	In distribution
42-5121-009-12	Height 12 mm	In distribution
42-5120-001-10	Height 10 mm	In distribution
42-5121-004-18	Height 18 mm	In distribution
42-5222-002-16	Height 16 mm	In distribution
42-5224-006-18	Height 18 mm	In distribution
42-5224-007-14	Height 14 mm	In distribution
42-5124-007-20	Height 20 mm	In distribution
42-5121-011-20	Height 20 mm	In distribution
42-5226-001-14	Height 14 mm	In distribution
42-5222-003-12	Height 12 mm	In distribution
42-5121-005-12	CR Femur Sizes 8-9	In distribution
42-5121-005-20	Height 20 mm	In distribution
42-5222-006-13	Height 13 mm	In distribution
42-5120-001-12	Height 12 mm	In distribution
42-5221-005-10	Height 10 mm	In distribution
42-5121-007-14	Height 14 mm	In distribution
42-5121-006-11	CR Femur Sizes 4-5	In distribution
42-5222-006-12	Height 12 mm	In distribution
42-5221-008-18	Height 18 mm	In distribution
42-5221-004-11	Height 11 mm	In distribution
42-5221-003-18	Height 18 mm	In distribution
42-5121-002-14	Height 14 mm	In distribution
42-5222-004-16	Height 16 mm	In distribution
42-5121-003-12	Height 12 mm	In distribution
42-5224-008-20	Height 20 mm	In distribution
42-5220-002-13	Height 13 mm	In distribution
42-5221-001-13	Height 13 mm	In distribution
42-5124-003-13	Height 13 mm	In distribution
42-5224-009-16	Height 16 mm	In distribution
42-5121-004-13	Height 13 mm	In distribution
42-5122-007-20	Height 20 mm	In distribution
42-5221-001-13	Height 13 mm	In distribution
42-5224-004-20	Height 20 mm	In distribution
42-5222-001-14	Height 14 mm	In distribution
42-5122-002-11	Height 11 mm	In distribution
42-5126-007-18	Height 18 mm	In distribution
42-5222-007-16	Height 16 mm	In distribution
42-5220-006-14	Height 14 mm	In distribution
42-5221-002-13	Height 13 mm	In distribution
42-5221-011-13	Height 13 mm	In distribution
42-5226-007-16	Height 16 mm	In distribution
42-5220-005-11	Height 11 mm	In distribution
42-5224-001-20	Height 20 mm	In distribution
42-5222-002-10	Height 10 mm	In distribution
42-5121-008-18	Height 18 mm	In distribution
42-5126-001-10	Height 10 mm	In distribution
42-5121-008-13	CR Femur Sizes 8-11	In distribution
42-5124-010-11	Height 11 mm	In distribution
42-5224-008-13	Height 13 mm	In distribution
42-5124-001-18	Height 18 mm	In distribution
42-5121-011-16	Height 16 mm	In distribution
42-5120-004-11	Height 11 mm	In distribution
42-5224-010-16	Height 16 mm	In distribution
42-5224-009-14	Height 14 mm	In distribution
42-5221-008-20	Height 20 mm	In distribution
42-5121-007-10	Height 10 mm	In distribution
42-5124-006-12	Height 12 mm	In distribution
42-5124-011-10	Height 10 mm	In distribution
42-5221-003-16	Height 16 mm	In distribution
42-5121-003-11	Height 11 mm	In distribution
42-5122-001-11	Height 11 mm	In distribution
42-5224-004-13	Height 13 mm	In distribution
42-5221-010-18	Height 18 mm	In distribution
42-5221-008-13	CR Femur Sizes 8-11	In distribution
42-5222-003-13	Height 13 mm	In distribution
42-5221-007-14	CR Femur Sizes 6-7	In distribution
42-5121-007-13	Height 13 mm	In distribution
42-5224-006-11	Height 11 mm	In distribution
42-5222-001-20	Height 20 mm	In distribution
42-5221-002-11	Height 11 mm	In distribution
42-5121-002-12	Height 12 mm	In distribution
42-5121-003-14	Height 14 mm	In distribution
42-5224-011-12	Height 12 mm	In distribution
42-5221-007-18	CR Femur Sizes 6-7	In distribution
42-5222-007-14	Height 14 mm	In distribution
42-5124-007-14	Height 14 mm	In distribution
42-5121-010-14	Height 14 mm	In distribution
42-5220-001-13	Height 13 mm	In distribution
42-5122-003-18	Height 18 mm	In distribution
42-5221-011-13	CR Femur Size 12	In distribution
42-5122-001-12	Height 12 mm	In distribution
42-5221-006-18	Height 18 mm	In distribution
42-5222-003-20	Height 20 mm	In distribution
42-5224-008-10	Height 10 mm	In distribution
42-5120-005-11	Height 11 mm	In distribution
42-5121-008-20	Height 20 mm	In distribution
42-5121-005-14	Height 14 mm	In distribution
42-5226-002-11	Height 11 mm	In distribution
42-5121-010-12	Height 12 mm	In distribution
42-5122-005-16	Height 16 mm	In distribution
42-5121-002-20	Height 20 mm	In distribution
42-5121-008-14	CR Femur Sizes 8-11	In distribution
42-5126-001-16	Height 16 mm	In distribution
42-5121-010-18	Height 18 mm	In distribution
42-5224-005-10	Height 10 mm	In distribution
42-5220-003-13	Height 13 mm	In distribution
42-5121-004-14	CR Femur Sizes 6-7	In distribution
42-5124-010-20	Height 20 mm	In distribution
42-5126-008-18	Height 18 mm	In distribution
42-5122-003-20	Height 20 mm	In distribution
42-5221-005-11	CR Femur Sizes 8-9	In distribution
42-5120-001-11	Height 11 mm	In distribution
42-5121-002-14	CR Femur Sizes 3-4	In distribution
42-5126-003-10	Height 10 mm	In distribution
42-5124-002-16	Height 16 mm	In distribution
42-5124-003-12	Height 12 mm	In distribution
42-5124-005-16	Height 16 mm	In distribution
42-5126-009-13	Height 13 mm	In distribution
42-5124-009-16	Height 16 mm	In distribution
42-5226-007-12	Height 12 mm	In distribution
42-5126-008-10	Height 10 mm	In distribution
42-5221-009-16	CR Femur Sizes 8-11	In distribution
42-5226-003-12	Height 12 mm	In distribution
42-5221-007-16	Height 16 mm	In distribution
42-5224-003-18	Height 18 mm	In distribution
42-5221-010-16	Height 16 mm	In distribution
42-5221-010-10	CR Femur Size 12	In distribution
42-5221-009-20	Height 20 mm	In distribution
42-5121-002-11	CR Femur Sizes 3-4	In distribution
42-5221-001-12	Height 12 mm	In distribution
42-5122-003-13	Height 13 mm	In distribution
42-5124-008-13	Height 13 mm	In distribution
42-5124-001-12	Height 12 mm	In distribution
42-5126-008-13	Height 13 mm	In distribution
42-5122-005-18	Height 18 mm	In distribution
42-5120-001-18	Height 18 mm	In distribution
42-5121-011-13	Height 13 mm	In distribution
42-5221-004-13	Height 13 mm	In distribution
42-5221-005-12	Height 12 mm	In distribution
42-5226-008-10	Height 10 mm	In distribution
42-5121-008-12	Height 12 mm	In distribution
42-5121-006-16	Height 16 mm	In distribution
42-5224-007-11	Height 11 mm	In distribution
42-5121-004-16	Height 16 mm	In distribution
42-5124-010-16	Height 16 mm	In distribution
42-5124-004-10	Height 10 mm	In distribution
42-5221-002-12	CR Femur Sizes 3-4	In distribution
42-5224-006-12	Height 12 mm	In distribution
42-5221-008-20	Height 20 mm	In distribution
42-5121-002-18	Height 18 mm	In distribution
42-5221-001-20	Height 20 mm	In distribution
42-5120-007-14	Height 14 mm	In distribution

Showing 250 of 286 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Prophecy®	Microport Orthopedics Inc.	4,423
Exult Knee Replacement System	Corentec Co., Ltd.	1,770
Freedom	Maxx Orthopedics Inc.	1,693
Legion	Smith & Nephew, Inc.	1,534
MyKnee	Medacta International SA	1,466
Journey	Smith & Nephew, Inc.	1,339
Persona®	Zimmer, Inc.	1,254
DJO Surgical	Encore Medical, L.P.	1,131
U2 Total Knee System	United Orthopedic Corp.	1,078
CKS Plus	Shalby Advanced Technologies, Inc.	1,024
Lospa Modular Knee System	Corentec Co., Ltd.	1,020
Natural-Knee®	Zimmer, Inc.	980

Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K243724	2025-03-06
K230321	2023-03-08
K221479	2022-11-17
K210829	2021-05-18
K210551	2021-03-18
K200209	2020-03-24
K193223	2020-01-24
K191625	2019-09-05
K190068	2019-06-04
K183583	2019-05-10
K181947	2018-10-25
K173057	2018-03-29
K152494	2015-11-25
K142787	2014-12-22
K133737	2014-02-04
K130143	2013-02-22
K122765	2012-11-09
K113369	2012-03-27
K073286	2008-03-07
K072281	2007-09-06
K062768	2006-10-13
K061882	2006-08-01
K060722	2006-05-26
K060370	2006-04-28
K052879	2005-11-22
K050723	2005-04-20
K043101	2005-03-07
K042271	2004-10-13
K023211	2002-10-17
K013991	2001-12-27
K003910	2001-03-19
K991581	1999-07-30
K972774	1999-05-05
K972270	1997-11-24
K963148	1997-02-13
K962196	1996-08-23
K960279	1996-04-26
K951185	1996-03-15
K946150	1995-07-11
K933785	1995-01-30
K930831	1993-11-16
K911572	1991-07-01
K895639	1990-02-08
K892800	1989-08-03
K872379	1987-10-28
K863805	1986-12-02
K853661	1985-12-09
K834432	1984-04-11
K833363	1984-02-13
K830121	1983-04-26
K790219	1979-05-08

Recalls Naming This Product

12 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Persona® Vivacit-E®
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Zimmer, Inc.	510(k) number	2016-05-11	Class II	Component design/selection	Zimmer Inc. is initiating a recall of specific Persona” Trabecular Metal” Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants.	10,256	2017-06-02
Zimmer, Inc.	510(k) number	2015-01-28	Class II	Under Investigation by firm	An increase in complaints of loosening and radiolucent lines.	11,658	2018-03-13
Zimmer, Inc.	510(k) number	2014-12-11	Class II	Device Design	Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, TASP shims must be manually cleaned and i	67963	2015-10-23
Zimmer, Inc.	510(k) number	2014-08-07	Class II	Device Design	Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument	77,737 units total	2015-01-27
Zimmer, Inc.	510(k) number	2014-08-07	Class II	Device Design	Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument	77,737 units total	2015-01-27
Zimmer, Inc.	510(k) number	2014-08-07	Class II	Device Design	Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument	77,737 total units	2015-01-27
Zimmer, Inc.	510(k) number	2014-08-07	Class II	Device Design	Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument	77,737 total units	2015-01-27
Zimmer, Inc.	510(k) number	2014-08-07	Class II	Device Design	Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument	77,737 total units	2015-01-27
Zimmer, Inc.	510(k) number	2014-08-07	Class II	Device Design	Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument	77,737 total units	2015-01-27
Zimmer, Inc.	510(k) number	2013-06-10	Class II	Device Design	Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer’s corrective actions taken earlier this year concerning the TASPs.	70,986 distribution events	2014-09-11
Zimmer, Inc.	510(k) number	2013-06-10	Class II	Device Design	Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer’s corrective actions taken earlier this year concerning the TASPs.	70,986 distribution events	2014-09-11
Zimmer, Inc.	510(k) number	2013-06-10	Class II	Device Design	Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer’s corrective actions taken earlier this year concerning the TASPs.	70,986 distribution events	2014-09-11

Recalls

40 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2025-02-27	Class II	Labeling Change Control	The “Use with plate 7, 8, 9, 10” compatibility statement on top of the label does not match with the compatibility statements “USE WITH PLATE 5, 6” in the translations section of the same label.	76 units
2025-01-06	Class II	Process change control	It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.	155 units
2025-01-06	Class II	Process change control	It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.	155 units
2024-03-28	Class II	Process change control	Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.	5,546 units
2023-05-19	Class II	Under Investigation by firm	Device outer packaging was incorrectly labeled.		2026-05-29
2022-12-06	Class II	Under Investigation by firm	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit	1366
2022-12-06	Class II	Under Investigation by firm	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit	1049
2022-12-06	Class II	Under Investigation by firm	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit	1673
2022-12-06	Class II	Under Investigation by firm	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit	2092
2022-12-06	Class II	Under Investigation by firm	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit	284
2022-12-06	Class II	Under Investigation by firm	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit	2460
2019-10-10	Class II	Packaging change control	Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).	5,459,583 total devices	2020-05-19
2019-10-10	Class II	Packaging change control	Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).	5,459,583 total devices	2020-05-19
2018-10-31	Class II	Process control	Screw is missing from the package	19 units	2019-04-08
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-11-29	Class II	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.	13,227 in total	2020-04-02
2017-08-07	Class II	Under Investigation by firm	There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the	842 products in total	2018-08-23
2017-08-07	Class II	Under Investigation by firm	There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the	842 products in total	2018-08-23
2017-08-07	Class II	Under Investigation by firm	There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the	842 products in total	2018-08-23
2017-08-07	Class II	Under Investigation by firm	There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the	842 products in total	2018-08-23
2017-04-28	Class II	Under Investigation by firm	Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorr	24	2018-07-03
2016-01-11	Class II	Process control	LDPE bag containing the implant adheres to the highly polished implant surface.	32508	2017-05-23
2016-01-11	Class II	Process control	LDPE bag containing the implant adheres to the highly polished implant surface.	88389	2017-05-23
2016-01-11	Class II	Process control	LDPE bag containing the implant adheres to the highly polished implant surface.	117359	2017-05-23
2016-01-11	Class II	Process control	LDPE bag containing the implant adheres to the highly polished implant surface.	42064	2017-05-23
2016-01-11	Class II	Process control	LDPE bag containing the implant adheres to the highly polished implant surface.	61485	2017-05-23
2016-01-11	Class II	Process control	LDPE bag containing the implant adheres to the highly polished implant surface.	18093	2017-05-23
2016-01-11	Class II	Process control	LDPE bag containing the implant adheres to the highly polished implant surface.	84396	2017-05-23

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.