ATTUNE¿ FIXED BEARING KNEE — Class II medical device recall Z-1314-2021
Terminated recall by DePuy Orthopaedics, Inc., reported 2021-04-07, distributed nationwide. Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential dam
| Recall number | Z-1314-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2021-02-22 |
| Classified | 2021-03-29 |
| Reported by FDA | 2021-04-07 |
| Terminated | 2023-10-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BR, CH, CN, DE, DK, EE, FR, GB, HK, IE, IL, IT, JP, KR, NL, NO, NZ, PL, RO, SE, SG, SI, SK, TH, ZA |
| UPC / GTIN / UDI-DI | 10603295492054, 10603295492061, 10603295492078, 10603295492085, 10603295492092, 10603295492108, 10603295492115 |
| Lot numbers | 9554006, 9555613, 9555958, 9556397, 9557992, 9558238, 9558239, 9558300, 9558618 |
Product
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.
Reason for recall
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1314-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.