Smith and Nephew EVOS Self-Tapping Locking Screw SST: — Class II medical device recall Z-0265-2022
Ongoing recall by Smith & Nephew, Inc., reported 2021-11-24, distributed in AL, AZ, CA, CO, CT, FL, GA, IL…. The labels on the packages of screws were switched.
| Recall number | Z-0265-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2021-10-25 |
| Classified | 2021-11-18 |
| Reported by FDA | 2021-11-24 |
| Distributed | AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, WA |
| Countries outside the US | AU, CA, CN, DE, IT, JP, NL, SG, TH |
| Quantity | 224 units |
| Reason classes | labeling |
| Lot numbers | 21FM24289, 21GM04743 |
| Model numbers | 3.5MM, 3.5MMX, 70MM, 72413570, 72413575, 75MM |
Product
Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
Reason for recall
The labels on the packages of screws were switched.
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-0265-2022. 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.