ULTRA FAST-FIX AB ASSEMBLY — Class II medical device recall Z-0144-2021
Ongoing recall by Smith & Nephew, Inc., reported 2020-10-28, distributed nationwide. Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a bre
| Recall number | Z-0144-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Andover, MA, United States |
| Recall initiated | 2020-09-09 |
| Classified | 2020-10-21 |
| Reported by FDA | 2020-10-28 |
| Distributed | Nationwide (US) |
| Quantity | 263,874 |
| Reason classes | sterility, packaging |
| Lot numbers | 2023195, 2023243, 2024953, 2024956, 2025090, 2025122, 2025379, 2025380, 2026563, 2027357, 2027362, 2027367, 2027371, 2028643, 2029177, 2029178, 2029179, 2029180, 2029213, 2030836, 2030837, 2030853, 2030854, 2030869, 2030870, 2030871, 2030872, 2030883, 2030884, 2032840, 2033307, 2033418, 2033554, 2035383, 2035384, 2035403, 2035404, 2035413, 2035428, 2036762 and 46 more |
Product
ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
Reason for recall
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the 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-0144-2021. 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.