Fitmore Hip Stem — Class II medical device recall Z-0320-2020
Terminated recall by Zimmer Biomet, Inc., reported 2019-11-13, distributed nationwide. Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
| Recall number | Z-0320-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2019-10-10 |
| Classified | 2019-11-07 |
| Reported by FDA | 2019-11-13 |
| Terminated | 2020-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 5,459,583 devices |
| Model numbers | 0100551102, 0100551103, 0100551104, 0100551105, 0100551106, 0100551107, 0100551108, 0100551109, 0100551110, 0100551111, 0100551112, 0100551113, 0100551114, 0100551201, 0100551202, 0100551203, 0100551204, 0100551205, 0100551206, 0100551207, 0100551208, 0100551209, 0100551210, 0100551211, 0100551212 and 30 more |
Product
Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 0100551105 0100551106 0100551107 0100551108 0100551109 0100551110 0100551111 0100551112 0100551113 0100551114 0100551201 0100551202 0100551203 0100551204 0100551205 0100551206 0100551207 0100551208 0100551209 0100551210 0100551211 0100551212 0100551213 0100551214 0100551301 0100551302 0100551303 0100551304 0100551305 0100551306 0100551307 0100551308 0100551309 0100551310 0100551311 0100551312 0100551313 0100551314 0100551401 0100551402 0100551403 0100551404 0100551405 0100551406 0100551407 0100551408 0100551409 0100551410 0100551411 0100551412 0100551413 0100551414
Reason for recall
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
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-0320-2020. 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.