Dall Miles SM GRIP AND 2 1 — Class II medical device recall Z-0645-2022
Ongoing recall by Howmedica Osteonics Corp., reported 2022-02-23, distributed in PR. There is a potential for the outer Tyvek lid to de-bond from the sealed package.
| Recall number | Z-0645-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2021-12-21 |
| Classified | 2022-02-16 |
| Reported by FDA | 2022-02-23 |
| Distributed | PR |
| Countries outside the US | CA, MY |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 07613327013306 |
| Lot numbers | 87458602 |
| Model numbers | 6704-0-110 |
Product
Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
Reason for recall
There is a potential for the outer Tyvek lid to de-bond 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-0645-2022. 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.