Persona®
Persona is Zimmer Biomet’s primary total knee implant system. Its components include a femoral implant, a tibial implant and a bearing positioned between them. The system offers different…
Persona is Zimmer Biomet’s primary total knee implant system. Its components include a femoral implant, a tibial implant and a bearing positioned between them. The system offers different sizes and designs so a surgeon can select components for the planned knee replacement configuration.
The family includes cruciate-retaining and cruciate-sacrificing options, as well as cemented and cementless versions. Femoral and tibial components are offered for left and right knees, with bearing choices that shape the construct.
Component Families
Zimmer Biomet lists side-specific femoral and tibial components, several bearing thicknesses and polyethylene options. Those choices define combinations within the Persona system.
8manufacturers in China registered for this device type
552catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | OIY |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K181947 |
| Record published | 2018-11-14 |
| Record revised | 2022-03-22 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 30 to 175 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 42-5890-078-00 | Size 13 | In distribution |
| 42-5046-066-02 | Size 9 | In distribution |
| 42-5860-074-10 | Sizes G, H, 10 mm | In distribution |
| 42-5892-006-30 | Sizes 3, 3+, 4, 5, 5+ / E, F | In distribution |
| 110038023 | Size 13 | In distribution |
| 42-5892-001-10 | Sizes 1, 1+ / A, B | In distribution |
| 42-5860-052-10 | Sizes E, F, 10 mm | In distribution |
| 42-5890-006-03 | In distribution | |
| 42-5870-058-02 | Size A, 0 Degree | In distribution |
| 110038047 | In distribution | |
| 42-5558-012-15 | Size AB, 15 mm, Thickness | In distribution |
| 42-5890-054-01 | Sizes 3, 3+ | In distribution |
| 42-5860-072-15 | Sizes G, H, 15 mm | In distribution |
| 42-5891-005-20 | Sizes 6, 7, 7+, 8, 9, 9+ / C, D | In distribution |
| 42-5606-135-22 | 22 mm, Diameter, +135 mm, Length, 6 mm Offset | In distribution |
| 42-5890-001-06 | 6 Degree | In distribution |
| 42-5830-056-00 | In distribution | |
| 110040867 | 20 mm | In distribution |
| 42-5566-078-10 | Size 13, 10 mm, Thickness | In distribution |
| 42-5600-135-14 | 14 mm, Diameter, +135 mm, Length | In distribution |
| 110046261 | In distribution | |
| 42-5892-001-06 | Sizes A, B, +6 mm Thickness Bottom | In distribution |
| 42-5603-135-11 | 11 mm, Diameter, +135 mm, Length, 3 mm Offset | In distribution |
| 42-5600-135-16 | 16 mm, Diameter, +135 mm, Length | In distribution |
| 42-5870-010-21 | Sizes A, B | In distribution |
| 42-5860-054-15 | Sizes E, F, 15 mm | In distribution |
| 42-5870-071-02 | Size E, 0 Degree | In distribution |
| 42-5891-002-10 | Sizes 3, 3+, 5, 5+ / A, B | In distribution |
| 42-5806-135-11 | Length 135.00 mm | In distribution |
| 42-5860-034-05 | Sizes C, D, 5 mm | In distribution |
| 42-5830-079-02 | 0 Degree, Size G | In distribution |
| 110043596 | In distribution | |
| 42-5866-058-15 | Sizes 5, 5+, 15 mm | In distribution |
| 42-5891-008-10 | Sizes 11, 11+ / E, F | In distribution |
| 42-5830-083-02 | 0 Degree, Size H | In distribution |
| 110037789 | In distribution | |
| 42-5870-010-02 | Sizes C, D, E, F | In distribution |
| 42-5606-175-20 | 20 mm, Diameter, +175 mm, Length, 6 mm Offset | In distribution |
| 42-5860-071-15 | Sizes G, H, 15 mm | In distribution |
| 110038089 | In distribution | |
| 42-5600-135-22 | 22 mm, Diameter, +135 mm, Length | In distribution |
| 42-5171-011-10 | Size 12 J | In distribution |
| 42-5846-058-11 | Size 5+ | In distribution |
| 42-5870-020-03 | Sizes G, H, J | In distribution |
| 42-5801-175-24 | Length 175.00 mm | In distribution |
| 42-5420-088-01 | Size J | In distribution |
| 42-5558-092-10 | Size J, 10 mm, Thickness | In distribution |
| 42-5870-058-01 | Size A, 0 Degree | In distribution |
| 42-5868-066-10 | Sizes 9, 9+, 10 mm | In distribution |
| 42-5891-009-06 | Size J, +6 mm Thickness Bottom | In distribution |
| 42-5700-056-01 | Size 4 | In distribution |
| 42-5870-003-02 | In distribution | |
| 42-5558-073-15 | Size GH, 15 mm, Thickness | In distribution |
| 42-5376-001-01 | 16-20 mm Thickness | In distribution |
| 42-5891-008-30 | Sizes 10, 11, 11+ / E, F | In distribution |
| 110038016 | Size 1/1+ | In distribution |
| 42-5846-066-01 | Size 9 | In distribution |
| 42-5830-058-03 | 0 Degree, Size A | In distribution |
| 42-5606-135-13 | 13 mm, Diameter, +135 mm, Length, 6 mm Offset | In distribution |
| 42-5830-012-01 | In distribution | |
| 110046272 | Size A-B | In distribution |
| 42-5279-008-02 | Size J 12 mm Thickness | In distribution |
| 42-5606-175-12 | 12 mm, Diameter, +175 mm, Length, 6 mm Offset | In distribution |
| 42-5860-034-15 | Sizes C, D, 15 mm | In distribution |
| 42-5892-007-30 | Sizes 6, 7, 7+, 8, 9, 9+ / E, F | In distribution |
| 42-5830-061-04 | 0 Degree, Size B | In distribution |
| 110043603 | In distribution | |
| 110037783 | In distribution | |
| 110046263 | In distribution | |
| 42-5860-053-10 | Sizes E, F, 10 mm | In distribution |
| 42-5558-012-10 | Size AB, 10 mm, Thickness | In distribution |
| 42-5890-010-12 | In distribution | |
| 42-5801-175-18 | 18 mm Diameter | In distribution |
| 110043607 | In distribution | |
| 42-5720-052-01 | Size 2 | In distribution |
| 42-5566-070-10 | Size 11, 11+, 10 mm, Thickness | In distribution |
| 42-5568-078-10 | Size 13, 10 mm, Thickness | In distribution |
| 42-5046-066-01 | Size 9 | In distribution |
| 42-5420-067-02 | Size D | In distribution |
| 42-5801-175-16 | Length 175.00 mm | In distribution |
| 42-5890-010-23 | In distribution | |
| 42-5890-020-63 | In distribution | |
| 42-5830-014-01 | In distribution | |
| 42-5806-175-11 | Length 175.00 mm | In distribution |
| 42-5891-006-10 | Sizes 3, 3+, 5, 5+ / E, F | In distribution |
| 42-5830-058-02 | 0 Degree, Size A | In distribution |
| 42-5600-175-24 | 24 mm, Diameter, +175 mm, Length | In distribution |
| 42-5376-001-02 | 22-26 mm Thickness | In distribution |
| 42-5892-001-30 | Sizes 1, 1+, 2 / A, B | In distribution |
| 42-5870-015-58 | In distribution | |
| 42-5866-078-10 | Size 13, 10 mm | In distribution |
| 42-5892-003-30 | Sizes 1, 1+, 2 / C, D | In distribution |
| 42-5892-003-06 | Sizes C, D, +6 mm Thickness Bottom | In distribution |
| 42-5601-135-11 | 11 mm, Diameter, +135 mm, Length | In distribution |
| 42-5892-001-12 | Sizes A, B, +12 mm Thickness Bottom | In distribution |
| 42-5558-033-05 | Size CD, 5 mm, Thickness | In distribution |
| 42-5890-003-00 | In distribution | |
| 110040847 | Size 6 | In distribution |
| 00-5907-081-90 | In distribution | |
| 42-5892-010-10 | Sizes 11, 11+, 13 / G, H | In distribution |
| 42-5891-009-00 | Size J, +0 mm Thickness Bottom | In distribution |
| 42-5870-083-02 | Size H, 0 Degree | In distribution |
| 42-5606-175-10 | 10 mm, Diameter, +175 mm, Length, 6 mm Offset | In distribution |
| 42-5558-034-15 | Size CD, 15 mm, Thickness | In distribution |
| 42-5601-175-22 | 22 mm, Diameter, +175 mm, Length | In distribution |
| 42-5279-004-01 | Size EF, 11 mm Thickness | In distribution |
| 42-5860-011-15 | Sizes A, B, 15 mm | In distribution |
| 42-5891-055-04 | Sizes E, F, 14 mm Thickness | In distribution |
| 110038017 | Size 3/3+ | In distribution |
| 42-5830-010-11 | 11 mm Diameter | In distribution |
| 42-5700-050-01 | Size 1 | In distribution |
| 42-5046-062-01 | Size 7 | In distribution |
| 42-5558-054-10 | Size EF, 10 mm, Thickness | In distribution |
| 42-5801-135-15 | 15 mm Diameter | In distribution |
| 42-5890-020-62 | In distribution | |
| 42-5891-009-10 | Sizes 7, 7+, 9, 9+ / G, H | In distribution |
| 42-5568-078-15 | Size 13, 15 mm, Thickness | In distribution |
| 42-5860-053-15 | Sizes E, F, 15 mm | In distribution |
| 42-5276-001-11 | Size AB, +6 Thickness Bottom | In distribution |
| 42-5720-060-02 | Size 6 | In distribution |
| 42-5706-070-02 | Size 11 | In distribution |
| 42-5558-052-05 | Size EF, 5 mm, Thickness | In distribution |
| 42-5806-135-14 | Length 135.00 mm | In distribution |
| 42-5568-050-10 | Size 1, 1+, 10 mm, Thickness | In distribution |
| 42-5700-054-02 | Size 3 | In distribution |
| 42-5892-001-00 | Sizes A, B, +0 mm Thickness Bottom | In distribution |
| 42-5870-064-02 | Size C, 0 Degree | In distribution |
| 42-5601-135-17 | 17 mm, Diameter, +135 mm, Length | In distribution |
| 42-5803-175-18 | Length 175.00 mm | In distribution |
| 42-5601-135-16 | 16 mm, Diameter, +135 mm, Length | In distribution |
| 42-5601-175-11 | 11 mm, Diameter, +175 mm, Length | In distribution |
| 42-5891-007-10 | Sizes 7, 7+, 9, 9+ / E, F | In distribution |
| 110046273 | Size C-D | In distribution |
| 110040850 | Size 9 | In distribution |
| 110046271 | In distribution | |
| 42-5860-074-05 | Sizes G, H, 5 mm | In distribution |
| 110037800 | In distribution | |
| 42-5892-009-20 | Sizes 6, 7, 7+, 8, 9, 9+ / G, H | In distribution |
| 42-5566-062-10 | Size 7, 7+, 10 mm, Thickness | In distribution |
| 42-5806-175-24 | 24 mm Diameter, 6 mm Offset | In distribution |
| 42-5279-006-01 | Size GH, 11 mm Thickness | In distribution |
| 42-5892-007-00 | Sizes G, H, +0 mm Thickness Bottom | In distribution |
| 42-5860-033-10 | Sizes C, D, 10 mm | In distribution |
| 42-5860-051-10 | Sizes E, F, 10 mm | In distribution |
| 42-5860-073-10 | Sizes G, H, 10 mm | In distribution |
| 42-5891-005-00 | Sizes E, F, +0 mm Thickness Bottom | In distribution |
| 42-5706-064-01 | Size 8 | In distribution |
| 42-5558-013-15 | Size AB, 15 mm, Thickness | In distribution |
| 42-5870-075-01 | Size F, 0 Degree | In distribution |
| 42-5830-010-22 | 22 mm Diameter | In distribution |
| 42-5890-010-24 | In distribution | |
| 110040920 | In distribution | |
| 42-5803-175-17 | Length 175.00 mm | In distribution |
| 110038062 | Size E-F | In distribution |
| 110040857 | 7° | In distribution |
| 110037786 | In distribution | |
| 42-5866-062-15 | Sizes 7, 7+, 15 mm | In distribution |
| 42-5846-066-22 | Sizes 9, 9+ | In distribution |
| 42-5558-033-10 | Size CD, 10 mm, Thickness | In distribution |
| 42-5046-062-11 | Size 7+ | In distribution |
| 42-5568-062-05 | Size 7, 7+, 5 mm, Thickness | In distribution |
| 42-5891-055-00 | Sizes E, F, 10 mm Thickness | In distribution |
| 42-5606-175-13 | 13 mm, Diameter, +175 mm, Length, 6 mm Offset | In distribution |
| 42-5870-010-01 | Sizes A, B | In distribution |
| 42-5860-093-05 | Size J, 5 mm | In distribution |
| 42-5420-064-02 | Size C | In distribution |
| 42-5891-010-10 | Sizes 11, 11+, 13 / G, H | In distribution |
| 42-5892-007-20 | Sizes 6, 7, 7+, 8, 9, 9+ / E, F | In distribution |
| 42-5868-062-15 | Sizes 7, 7+, 15 mm | In distribution |
| 110040840 | In distribution | |
| 42-5601-175-15 | 15 mm, Diameter, +175 mm, Length | In distribution |
| 42-5046-078-02 | Size 13 | In distribution |
| 42-5846-050-01 | Size 1 | In distribution |
| 42-5271-005-10 | Size 8-9 CD | In distribution |
| 42-5830-010-15 | 15 mm Diameter | In distribution |
| 42-5892-003-10 | Sizes 1, 1+ / C, D | In distribution |
| 42-5558-093-05 | Size J, 5 mm, Thickness | In distribution |
| 42-5046-050-01 | Size 1 | In distribution |
| 42-5830-061-03 | 0 Degree, Size B | In distribution |
| 42-5870-005-53 | In distribution | |
| 42-5046-070-02 | Size 11 | In distribution |
| 42-5100-330-78 | In distribution | |
| 42-5720-054-01 | Size 3 | In distribution |
| 42-5891-011-30 | Sizes 10, 11, 11+, 12, 13 / J | In distribution |
| 42-5860-012-10 | Sizes A, B, 10 mm | In distribution |
| 42-5830-064-03 | 0 Degree, Size C | In distribution |
| 42-5726-058-02 | Size 5 | In distribution |
| 42-5866-070-10 | Sizes 11, 11+, 10 mm | In distribution |
| 42-5890-050-01 | Sizes 1, 1+ | In distribution |
| 42-5860-072-10 | Sizes G, H, 10 mm | In distribution |
| 42-5568-058-10 | Size 5, 5+, 10 mm, Thickness | In distribution |
| 42-5830-071-03 | 0 Degree, Size E | In distribution |
| 42-5830-075-03 | 0 Degree, Size F | In distribution |
| 42-5558-011-10 | Size AB, 10 mm, Thickness | In distribution |
| 42-5870-005-12 | In distribution | |
| 110037983 | In distribution | |
| 110038046 | In distribution | |
| 42-5047-005-11 | Size 4-5 | In distribution |
| 110043604 | In distribution | |
| 42-5870-020-21 | Sizes A, B | In distribution |
| 42-5803-175-20 | 20 mm Diameter, 3 mm Offset | In distribution |
| 42-5600-135-24 | 24 mm, Diameter, +135 mm, Length | In distribution |
| 42-5891-004-20 | Sizes 3, 3+, 4, 5, 5+ / C, D | In distribution |
| 42-5891-007-12 | Sizes G, H, +12 mm Thickness Bottom | In distribution |
| 42-5891-004-30 | Sizes 3, 3+, 4, 5, 5+ / C, D | In distribution |
| 42-5803-135-12 | 12 mm Diameter, 3 mm Offset | In distribution |
| 42-5600-135-12 | 12 mm, Diameter, +135 mm, Length | In distribution |
| 110037792 | In distribution | |
| 110038011 | Size 11 | In distribution |
| 42-5846-054-11 | Size 3+ | In distribution |
| 42-5803-175-13 | 13 mm Diameter, 3 mm Offset | In distribution |
| 110038063 | Size E-F | In distribution |
| 42-5868-058-10 | Sizes 5, 5+, 10 mm | In distribution |
| 42-5603-175-13 | 13 mm, Diameter, +175 mm, Length, 3 mm Offset | In distribution |
| 42-5870-005-22 | In distribution | |
| 42-5726-064-01 | Size 8 | In distribution |
| 110038049 | In distribution | |
| 42-5601-135-24 | 24 mm, Diameter, +135 mm, Length | In distribution |
| 42-5720-050-01 | Size 1 | In distribution |
| 42-5870-005-31 | In distribution | |
| 42-5271-006-10 | Size 4-5 EF | In distribution |
| 42-5279-006-04 | Size GH 14 mm Thickness | In distribution |
| 42-5700-056-02 | Size 4 | In distribution |
| 42-5892-006-10 | Sizes 3, 3+, 5, 5+ / E, F | In distribution |
| 42-5830-083-04 | 0 Degree, Size H | In distribution |
| 42-5860-032-15 | Sizes C, D, 15 mm | In distribution |
| 42-5279-008-03 | Size J, 13 mm Thickness | In distribution |
| 42-5830-088-04 | 0 Degree, Size J | In distribution |
| 42-5806-175-20 | Length 175.00 mm | In distribution |
| 42-5420-075-01 | Size F | In distribution |
| 42-5860-033-05 | Sizes C, D, 5 mm | In distribution |
| 42-5830-058-03 | 0 Degree, Size A | In distribution |
| 110040837 | In distribution | |
| 42-5860-092-05 | Size J, 5 mm | In distribution |
| 42-5566-062-15 | Size 7, 7+, 15 mm, Thickness | In distribution |
| 42-5870-083-01 | Size H, 0 Degree | In distribution |
| 42-5860-094-15 | Size J, 15 mm | In distribution |
| 42-5606-135-12 | 12 mm, Diameter, +135 mm, Length, 6 mm Offset | In distribution |
| 110037992 | In distribution | |
| 42-5870-020-02 | Sizes C, D, E, F | In distribution |
| 42-5603-135-24 | 24 mm, Diameter, +135 mm, Length, 3 mm Offset | In distribution |
| 42-5558-092-15 | Size J, 15 mm, Thickness | In distribution |
| 42-5846-050-11 | Size 1+ | In distribution |
| 42-5890-054-02 | Sizes 3, 3+ | In distribution |
| 42-5279-004-03 | Size EF, 13 mm Thickness | In distribution |
| 42-5558-091-05 | Size J, 5 mm, Thickness | In distribution |
| 42-5892-002-30 | Sizes 3, 3+, 4, 5, 5+ / A, B | In distribution |
| 42-5046-078-01 | Size 13 | In distribution |
| 42-5420-071-01 | Size E | In distribution |
| 42-5860-012-05 | Sizes A, B, 5 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 415 |
| Genflex2 Total Knee System | Globus Medical, Inc. | 389 |
| Persona® Vivacit-E® | Zimmer, Inc. | 332 |
| Truliant, Activit-E | Exactech, Inc. | 272 |
| TriVerse Meniscal Insert PS | Signature Orthopaedics PTY Limited | 220 |
| U2™ Knee | United Orthopedic Corp. | 195 |
| BKS E-Vitalize | Ortho Development Corp. | 193 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 169 |
| Attune | Depuy (Ireland) | 161 |
| Vanguard Complete Knee System | Biomet Orthopedics | 153 |
| EXp Tibial Inserts and Patellar Components | Globus Medical, Inc. | 144 |
| TriVerse Meniscal Insert AS | Signature Orthopaedics PTY Limited | 126 |
Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Recalls Naming This Product
11 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2026-05-11 | Class II | Labeling Change Control | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. | 12 | |
| 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 |
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.