The ATTUNE¿ Rotating Platform — Class II medical device recall Z-1316-2021
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-1316-2021 |
|---|---|
| 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 | 10603295492153, 10603295492160, 10603295492177, 10603295492184, 10603295492191 |
| Lot numbers | 9556100, 9556127, 9556128, 9557372, 9557376, 9557377, 9557434, 9557439, 9557440, 9557444, 9557445, 9557446, 9557450, 9557453, 9557455, 9557457, 9557460, 9557471, 9557473, 9557476 |
Product
The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
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-1316-2021. 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.