RENOVATION — Class II medical device recall Z-1911-2017
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-1911-2017 |
|---|---|
| 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 | 1,126 units |
| Reason classes | labeling, specification failure |
| Lot numbers | 07LSY0037, 07LSY0042, 08ESY0005, 08ESY0005A, 08ESY0007, 08ESY0008, 08JSY0009, 08JSY0009A, 08LSY0050, 09BSY0019, 09FSY0003, 10CSY0007, 10ESY0013, 11GSY0006, 11HSY0009, 11KSY0003, 11KSY0069, 11MSY0021, 12FSY0002, 12FSY0029, 12GSY0007, 12HSY0025, 12HSY0040, 12KSY0024, 12LSY0021, 12MSY0005, 12MSY0013, 12MSY0025, 13BSY0009, 13BSY0016, 13FSY0022, 13JSY0022, 13KSY0048, 13MSY0006, 14CSY0006, 14CSY0038, 14HSY0006, 15ASY0009, 15ASY0018, 15ASY0022 and 20 more |
| Model numbers | 71369314 |
Product
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, 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-1911-2017. 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.