RingLoc® Hip System
130 catalogue numbers from XL-105925, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
130catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (3), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| 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 |
Showing 12 of 15. All 15 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | LZO |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| 510(k) | K042051 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XL-105925 | 32MM HEAD SIZE 25 LINER SIZE | In distribution |
| 16-104170 | 70MM SHELL SIZE 28 LINER SIZE | In distribution |
| XL-196238 | 40MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-106997 | 38MM HEAD SIZE 27 LINER SIZE | In distribution |
| EP-108525 | 40MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-106985 | 38mm Head Size 25 Liner Size | In distribution |
| 16-104180 | 80MM SHELL SIZE 28 LINER SIZE | In distribution |
| XL-108221 | 28MM HEAD SIZE 21 LINER SIZE | In distribution |
| XL-195234 | 38mm Head Size 24 Liner Size | In distribution |
| XL-106986 | 38MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-106985 | 38MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-108425 | 40MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-109928 | 40MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-106995 | 38MM HEAD SIZE 25 LINER SIZE | In distribution |
| 11-105997 | 26MM HEAD SIZE 27 LINER SIZE | In distribution |
| XL-107927 | 40MM HEAD SIZE 27 LINER SIZE | In distribution |
| XL-108223 | 36MM HEAD SIZE 23 LINER SIZE | In distribution |
| 16-104146 | 46MM SHELL SIZE 22 LINER SIZE | In distribution |
| 105994 | 26MM HEAD SIZE 24 LINER SIZE | In distribution |
| XL-108321 | 28MM HEAD SIZE 21 LINER SIZE | In distribution |
| 11-105875 | 32MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-106987 | 38MM HEAD SIZE 27 LINER SIZE | In distribution |
| XL-156233 | 36MM HEAD SIZE 23 LINER SIZE | In distribution |
| 11-105877 | 32MM HEAD SIZE 27 LINER SIZE | In distribution |
| 11-105987 | 22MM HEAD SIZE 27 LINER SIZE | In distribution |
| XL-176235 | 40MM HEAD SIZE 25 LINER SIZE | In distribution |
| EP-105951 | 28mm Head Size 21 Liner Size | In distribution |
| XL-176237 | 40MM HEAD SIZE 27 LINER SIZE | In distribution |
| 16-116074 | 74MM SHELL SIZE 28 LINER SIZE | In distribution |
| XL-105884 | 28MM HEAD SIZE 24 LINER SIZE | In distribution |
| XL-108528 | 40MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-105927 | 32MM HEAD SIZE 27 LINER SIZE | In distribution |
| 11-105927 | 32MM HEAD SIZE 27 LINER SIZE | In distribution |
| XL-105895 | 36MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-166235 | 38MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-106885 | 38MM HEAD SIZE 25 LINER SIZE | In distribution |
| EP-108428 | 40MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-166237 | 38MM HEAD SIZE 27 LINER SIZE | In distribution |
| 16-104144 | 44MM SHELL SIZE 21 LINER SIZE | In distribution |
| XL-106998 | 38mm Head Size 28 Liner Size | In distribution |
| XL-166238 | 38MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-109927 | 40MM HEAD SIZE 27 LINER SIZE | In distribution |
| XL-105813 | 28MM HEAD SIZE 23 LINER SIZE | In distribution |
| XL-107827 | 40MM HEAD SIZE 27 LINER SIZE | In distribution |
| XL-106886 | 38MM HEAD SIZE 26 LINER SIZE | In distribution |
| 105906 | 28MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-106996 | 38mm Head Size 26 Liner Size | In distribution |
| XL-195237 | 38mm Head Size 27 Liner Size | In distribution |
| XL-106995 | 38mm Head Size 25 Liner Size | In distribution |
| 11-105995 | 26MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-195238 | 38MM HEAD SIZE 28 LINER SIZE | In distribution |
| 105925 | 32MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-107926 | 40MM HEAD SIZE 26 LINER SIZE | In distribution |
| 105991 | 26MM HEAD SIZE 21 LINER SIZE | In distribution |
| 11-105873 | 32MM HEAD SIZE 23 LINER SIZE | In distribution |
| XL-195236 | 38mm Head Size 26 Liner Size | In distribution |
| XL-107826 | 40MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-185235 | 36MM HEAD SIZE 25 LINER SIZE | In distribution |
| 105938 | 32MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-106988 | 38mm Head Size 28 Liner Size | In distribution |
| XL-185233 | 36MM HEAD SIZE 23 LINER SIZE | In distribution |
| XL-108323 | 36MM HEAD SIZE 23 LINER SIZE | In distribution |
| 11-105876 | 32MM HEAD SIZE 26 LINER SIZE | In distribution |
| 106024 | 24 SIZE | In distribution |
| XL-108526 | 40MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-105818 | 28MM HEAD SIZE 28 LINER SIZE | In distribution |
| 11-105991 | 26MM HEAD SIZE 21 LINER SIZE | In distribution |
| XL-105917 | 36MM HEAD SIZE 27 LINER SIZE | In distribution |
| 16-104160 | 60MM SHELL SIZE 25 LINER SIZE | In distribution |
| 105908 | 28MM HEAD SIZE 28 LINER SIZE | In distribution |
| 11-105992 | 26MM HEAD SIZE 22 LINER SIZE | In distribution |
| XL-176238 | 40MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-106998 | 38MM HEAD SIZE 28 LINER SIZE | In distribution |
| 11-105863 | 28MM HEAD SIZE 23 LINER SIZE | In distribution |
| 105923 | 32MM HEAD SIZE 23 LINER SIZE | In distribution |
| XL-196235 | 40MM HEAD SIZE 25 LINER SIZE | In distribution |
| 11-105855 | 26MM HEAD SIZE 25 LINER SIZE | In distribution |
| 11-105925 | 32MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-108524 | 40MM HEAD SIZE 24 LINER SIZE | In distribution |
| XL-166236 | 38MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-195235 | 38mm Head Size 25 Liner Size | In distribution |
| XL-195237 | 38MM HEAD SIZE 27 LINER SIZE | In distribution |
| 16-116076 | 76MM SHELL SIZE 28 LINER SIZE | In distribution |
| XL-185237 | 36MM HEAD SIZE 27 LINER SIZE | In distribution |
| XL-195238 | 38mm Head Size 28 Liner Size | In distribution |
| EP-108725 | 44MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-105888 | 28MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-185234 | 36MM HEAD SIZE 24 LINER SIZE | In distribution |
| XL-176236 | 40MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-106887 | 38MM HEAD SIZE 27 LINER SIZE | In distribution |
| 11-165307 | 67 SIZE 58/61MM SHELL SIZE | In distribution |
| XL-109926 | 40MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-106986 | 38mm Head Size 26 Liner Size | In distribution |
| 16-104172 | 72MM SHELL SIZE 28 LINER SIZE | In distribution |
| XL-105882 | 28MM HEAD SIZE 22 LINER SIZE | In distribution |
| 11-105857 | 26MM HEAD SIZE 27 LINER SIZE | In distribution |
| XL-105918 | 36MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-196236 | 40MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-105838 | 32MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-106996 | 38MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-196237 | 40MM HEAD SIZE 27 LINER SIZE | In distribution |
| 16-116042 | 42MM SHELL SIZE 20 LINER SIZE | In distribution |
| XL-195236 | 38MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-105883 | 28MM HEAD SIZE 23 LINER SIZE | In distribution |
| 11-105934 | 32MM HEAD SIZE 24 LINER SIZE | In distribution |
| 11-105861 | 28MM HEAD SIZE 21 LINER SIZE | In distribution |
| XL-106987 | 38mm Head Size 27 Liner Size | In distribution |
| XL-166234 | 38MM HEAD SIZE 24 LINER SIZE | In distribution |
| XL-195235 | 38MM HEAD SIZE 25 LINER SIZE | In distribution |
| 105935 | 32MM HEAD SIZE 25 LINER SIZE | In distribution |
| EP-108524 | 40MM HEAD SIZE 24 LINER SIZE | In distribution |
| XL-175232 | 32MM HEAD SIZE 22 LINER SIZE | In distribution |
| XL-105928 | 32MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-107828 | 40MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-106997 | 38mm Head Size 27 Liner Size | In distribution |
| 11-105825 | 22MM HEAD SIZE 42 LINER SIZE | In distribution |
| 105928 | 32MM HEAD SIZE 28 LINER SIZE | In distribution |
| 16-116058 | 58MM SHELL SIZE 25 LINER SIZE | In distribution |
| XL-185236 | 36MM HEAD SIZE 26 LINER SIZE | In distribution |
| 11-105900 | 22MM HEAD SIZE 20 LINER SIZE | In distribution |
| XL-156234 | 36MM HEAD SIZE 24 LINER SIZE | In distribution |
| XL-106888 | 38MM HEAD SIZE 28 LINER SIZE | In distribution |
| 11-105865 | 28MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-107928 | 40MM HEAD SIZE 28 LINER SIZE | In distribution |
| 11-105902 | 28MM HEAD SIZE 22 LINER SIZE | In distribution |
| XL-195234 | 38MM HEAD SIZE 24 LINER SIZE | In distribution |
| XL-185238 | 36MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-156236 | 36MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-106988 | 38MM HEAD SIZE 28 LINER SIZE | In distribution |
| 16-104178 | 78MM SHELL SIZE 28 LINER SIZE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Libertas | Maxx Orthopedics Inc. | 1,832 |
| Redapt | Smith & Nephew, Inc. | 326 |
| Bencox Hip System | Corentec Co., Ltd. | 295 |
| M-Vizion Femoral Revision System | Medacta International SA | 289 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Zimmer, Inc. | 280 |
| Profemur® | Microport Orthopedics Inc. | 229 |
| DJO Surgical | Encore Medical, L.P. | 162 |
| Instrument | Howmedica Osteonics Corp | 152 |
| Alteon | Exactech, Inc. | 151 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Exactech, Inc. | 136 |
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 136 |
| Wagner SL Revision® | Zimmer, Inc. | 133 |
Showing 12 of 691. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200196 | 2020-12-08 |
Recalls Naming This Product
57 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2024-05-17 | Class II | Labeling mix-ups | 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention | 12 units | |
| Biomet, Inc. | 510(k) number | 2020-11-25 | Class II | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. | 7428 | 2024-05-08 |
| Biomet, Inc. | 510(k) number | 2020-09-03 | Class II | Process control | Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or | 48 devices | 2022-12-20 |
| Biomet, Inc. | 510(k) number | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 58 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2017-06-29 | Class II | Employee error | Device was distributed with the etching missing from the product. | 15 units | 2018-03-07 |
| Biomet, Inc. | 510(k) number | 2017-02-17 | Class II | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. | 28,253 in total | 2018-01-29 |
| Biomet, Inc. | UDI-DI | 2016-12-19 | Class II | Under Investigation by firm | Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery. | 36 | 2017-09-19 |
| Biomet, Inc. | 510(k) number | 2015-07-28 | Class II | Under Investigation by firm | The device was assembled without screw hole plugs. | 5 | 2016-05-17 |
| Biomet, Inc. | 510(k) number | 2015-01-09 | Class II | Packaging process control | Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two. | 17 | 2015-10-22 |
| Biomet, Inc. | 510(k) number | 2012-02-07 | Not classified | Employee error | Biomet initiated this action after complaints were received where OOS AVL Bushing Sets were opened during OSS knee replacement procedures, and were found to contain two tabbed bushings. | 27 units distributed US and foreign | 2013-02-06 |
| Biomet, Inc. | 510(k) number | 2011-09-13 | Not classified | Nonconforming Material/Component | Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification. | 5 devices | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 10 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 49 units | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 762 all products | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 103 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 149 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 146 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 64 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 55 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 17 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 10 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 16 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 8 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 42 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 22 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 16 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 30 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 22 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 48 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 42 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 23 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 51 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 37 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 31 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 32 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 16 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 15 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 8 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 15 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 7 | 2011-09-16 |
Showing 40 of 57.
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.