Accolade and Restoration hip product — Class II medical device recall Z-0940-2018
Terminated recall by Howmedica Osteonics Corp., reported 2018-03-21, distributed in AR, DE, FL, IL, IN, MI, NJ, OH…. Inner and outer sterile barriers not fully sealed.
| Recall number | Z-0940-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2017-07-21 |
| Classified | 2018-03-09 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2020-03-12 |
| Distributed | AR, DE, FL, IL, IN, MI, NJ, OH, TN, TX |
| Countries outside the US | AU, CA, CO, ES, FR, GB, IT, JP, NL, RO, SE |
| Quantity | 255 |
| Reason classes | sterility |
| Lot numbers | 56211103, 56211401, 56211704, 57284004 |
| Model numbers | 6720-0837, 6721-0737 |
Product
Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
Reason for recall
Inner and outer sterile barriers not fully sealed.
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-0940-2018. 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.