BioSync Anatomic Cotton Wedge — Class II medical device recall Z-1961-2016
Terminated recall by Arthrex, Inc., reported 2016-06-22, distributed in CA, CO, FL, GA, IL, IN, KS, MD…. Potential for polystyrene particulate presence.
| Recall number | Z-1961-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrex, Inc., Naples, FL, United States |
| Recall initiated | 2016-04-22 |
| Classified | 2016-06-14 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-10-13 |
| Distributed | CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, WI |
| Quantity | 138 products |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00888867202733 |
| Lot numbers | 10019148 |
| Model numbers | AR-8948W-2045 |
Product
BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Reason for recall
Potential for polystyrene particulate presence.
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-1961-2016. 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.