OSTEORAPTOR 2 — Class II medical device recall Z-0152-2021
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-0152-2021 |
|---|---|
| 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) |
| Reason classes | sterility, packaging |
| Lot numbers | 2012909, 2012910, 2012911, 2012937, 2013912, 2013913, 2016202, 2016203, 2016230, 2018636, 2018637, 2018740, 2018795, 2021326, 2022258, 2023091, 2024439, 2024440, 2024441, 2024448, 2024449, 2025094, 2025098, 2025287, 2025288, 2025340, 2027388, 2027419, 2027453, 2027483, 2029073, 2029325, 2029326, 2029365, 2029366, 2030989, 2030990, 2031123, 2031125, 2031127 and 65 more |
Product
OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
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-0152-2021. 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.