CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis — Class II medical device recall Z-2450-2024
Ongoing recall by Zimmer, Inc., reported 2024-08-07, distributed nationwide. Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is bei
| Recall number | Z-2450-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2024-07-02 |
| Classified | 2024-07-30 |
| Reported by FDA | 2024-08-07 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00889024145733, 00889024145740, 00889024145757, 00889024145764, 00889024145771, 00889024145788, 00889024145795, 00889024145801, 00889024145818, 00889024145825, 00889024145832, 00889024145849, 00889024145856, 00889024145863, 00889024145870, 00889024145887, 00889024145894, 00889024145900, 00889024145917, 00889024145924, 00889024145931, 00889024145948, 00889024145955, 00889024145962, 00889024145979 |
| Model numbers | 00811400000, 00811400010, 00811400100, 00811400110, 00811400200, 00811400210, 00811400218, 00811400230, 00811400300, 00811400310, 00811400318, 00811400330, 00811400400, 00811400410, 00811400420, 00811400423, 00811400426, 00811400430, 00811400500, 00811400510, 00811400530, 00811401218, 00811401318, 00811404000, 00811405000 |
Product
CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 00811400410 00811400420 00811400423 00811400426 00811400430 00811400500 00811400510 00811400530 00811401218 00811401318 00811404000 00811405000
Reason for recall
Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.
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-2450-2024. 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.