Acufex Access Advanced Positioning Kit — Class II medical device recall Z-0635-2022
Ongoing recall by Smith & Nephew, Inc., reported 2022-02-16, distributed nationwide. Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did no
| Recall number | Z-0635-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2021-12-14 |
| Classified | 2022-02-10 |
| Reported by FDA | 2022-02-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 271 units |
| Lot numbers | 50967788, 50971615, 50971617 |
Product
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
Reason for recall
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
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-0635-2022. 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.