CLS Brevius Stem Kinectiv — Class II medical device recall Z-0319-2020
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-0319-2020 |
|---|---|
| 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 | 0100296050, 0100296060, 0100296070, 0100296080, 0100296090, 0100296100, 0100296112, 0100296125, 0100296137, 0100296150, 0100296162, 0100296175, 0100296200 |
Product
CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112 0100296125 0100296137 0100296150 0100296162 0100296175 0100296200
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-0319-2020. 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.