Total Knee Pack — Class II medical device recall Z-0864-2022
Ongoing recall by Stradis Medical, LLC dba Stradis Healthcare, reported 2022-04-13, distributed nationwide. The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
| Recall number | Z-0864-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stradis Medical, LLC dba Stradis Healthcare, Peachtree Corners, GA, United States |
| Recall initiated | 2022-02-25 |
| Classified | 2022-04-04 |
| Reported by FDA | 2022-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 76 units |
| Reason classes | sterility |
| Lot numbers | 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064 |
| Model numbers | 570-2676 |
Product
Total Knee Pack - Surgical Kit
Reason for recall
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
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-0864-2022. 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.