28MM -4 LFIT V40 HEAD — Class II medical device recall Z-0314-2022
Ongoing recall by Howmedica Osteonics Corp., reported 2021-12-08, distributed in PR. There is a potential for the outer white Tyvek lid to debond from the sealed package.
| Recall number | Z-0314-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2021-10-15 |
| Classified | 2021-11-30 |
| Reported by FDA | 2021-12-08 |
| Distributed | PR |
| UPC / GTIN / UDI-DI | 07613327013016 |
| Lot numbers | 86604305, 86604306 |
| Model numbers | 6260-9-122 |
Product
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Reason for recall
There is a potential for the outer white Tyvek lid to debond from the sealed package.
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-0314-2022. 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.