smith&nephew SMF — Class II medical device recall Z-1028-2019
Terminated recall by Smith & Nephew, Inc., reported 2019-03-27, distributed in AR, CA, FL, IN, MO, NC, TN. Complaints were received indicating that the outer label incorrectly identified the product as size "1" instea
| Recall number | Z-1028-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2019-02-19 |
| Classified | 2019-03-20 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2021-05-21 |
| Distributed | AR, CA, FL, IN, MO, NC, TN |
| Countries outside the US | CA, CN, DE, ES, FR, GB, IN, IT, JP, KR, MX, PL |
| Quantity | 58 units |
| Reason classes | labeling |
| Lot numbers | 11AM15163U, 11AM15184T, 11CM01097U, 15MM06466, 16EM13018, 16EM13035, 18CM08027 |
| Model numbers | 713552510 |
Product
smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
Reason for recall
Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
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-1028-2019. 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.