Class II — Zimmer, Inc.
| Recalling firm | ZIMMER, INC. |
|---|---|
| Registered facility | View this company's 10 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF. |
| 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 |
| Quantity | 5,500 (US); 242,000 (OUS) |
| Distribution | Worldwide - US Nationwide distribution. |
| Initiated | 2024-07-02 |
| Classified | 2024-07-30 |
| Recall number | Z-2450-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zimmer, Inc. (Z-2450-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94923/
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