StageOne Hip — Class II medical device recall Z-0399-2019
Terminated recall by Zimmer Biomet, Inc., reported 2018-11-14, distributed nationwide. There is a potential for comingling of the 43MM and 51 MM molds
| Recall number | Z-0399-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-09-21 |
| Classified | 2018-11-07 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2020-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 72 units |
| UPC / GTIN / UDI-DI | 00880304447141, 00880304447165 |
| Lot numbers | 705550, 705570, 705580 |
| Model numbers | 431207, 431209, 431209USAGE |
Product
StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cement, or equivalent, by injecting with a dispenser/gun into the mold. After the cement cures, the temporary spacers are to be removed from the molds with the reinforcement remaining as the core of the spacer, and placed into the joint space. The spacers remain in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional hip joint prosthesis.
Reason for recall
There is a potential for comingling of the 43MM and 51 MM molds
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-0399-2019. 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.