Suture Anchor — Class II medical device recall Z-2107-2021
Ongoing recall by Arthrex, Inc., reported 2021-07-28, distributed nationwide. Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch
| Recall number | Z-2107-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrex, Inc., Naples, FL, United States |
| Recall initiated | 2021-06-14 |
| Classified | 2021-07-21 |
| Reported by FDA | 2021-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 3,985 units |
| Reason classes | packaging |
| Lot numbers | 12758314, 13022357 |
| Model numbers | AR-2323BCC |
Product
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Reason for recall
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
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-2107-2021. 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.