RENOVATION — Class II medical device recall Z-1912-2017
Terminated recall by Smith & Nephew, Inc., reported 2017-05-10, distributed nationwide. The stability data does not support the product labeled with a 10-year shelf life.
| Recall number | Z-1912-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2017-03-30 |
| Classified | 2017-05-02 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2019-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CN, CO, CR, DK, EE, ES, FI, FR, GB, IN, IT, JP, MX, NL, NO, PL, RU, SE, SG, TH, TT, VE, ZA |
| Quantity | 1,004 units |
| Reason classes | labeling, specification failure |
| Lot numbers | 08CSY0044, 08ESY0009, 08ESY0010, 08ESY0011, 08JSY0034, 08LSY0010, 10CSY0008, 10ESY0014, 11KSY0004, 11KSY0024, 12BSY0006, 12BSY0014, 12DSY0020, 12HSY0009, 12HSY0041, 12MSY0026, 13BSY0032, 13FSY0012, 13FSY0023, 13HSY0008, 14BSY0015, 14CSY0039, 14GSY0025, 14KSY0003, 15DSY0002, 15FSY0020, 15MSY0006, 16BSY0010, 431604, 431612, 431614, 448956, 450002910, 4500029102, 4500031658, 477931, 477931B, 484324, 485498, 488987 and 1 more |
| Model numbers | 71369316 |
Product
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
Reason for recall
The stability data does not support the product labeled with a 10-year shelf life.
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-1912-2017. 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.