BIORAPTOR 2 — Class II medical device recall Z-2216-2013
Terminated recall by Smith & Nephew, Inc. Endoscopy Division, reported 2013-09-25, distributed nationwide. Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
| Recall number | Z-2216-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc. Endoscopy Division, Andover, MA, United States |
| Recall initiated | 2013-08-06 |
| Classified | 2013-09-17 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2016-04-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, ES, FI, FR, GB, GR, HK, IE, IL, IN, IT, JP, KR, LK, LU, MX, MY, NL, NO, NZ, PH, PL, PT, RU, SE, SG, SI, TH, TR, TW, UA, VE, ZA |
| Quantity | 24,574 us |
| Reason classes | sterility |
| Model numbers | 72200774 |
Product
BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor
Reason for recall
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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-2216-2013. 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.