RENOVATION — Class II medical device recall Z-1909-2017
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-1909-2017 |
|---|---|
| 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 | 1,535 units |
| Reason classes | labeling, specification failure |
| Lot numbers | 07MSY0014, 08CSY0043, 08CSY0050, 08CSY0053, 08CSY0053B, 08JSY0007, 08LSY0012, 08MSY0016, 10CSY0006, 10HSY0006, 11DSY0003, 11ESY0007, 11FSY0008, 11GSY0009, 11GSY0025, 11JSY0010, 11MSY0020, 12ASY0012, 12BSY0017, 12CSY0006, 12HSY0008, 12HSY0038, 12KSY0029, 12LSY0024, 12MSY0024, 13BSY0030, 13BSY0031, 13FSY0018, 13FSY0020, 13LSY0010, 13MSY0004, 14ASY0002, 14CSY0007, 14CSY0036, 14GSY0026, 14LSY0011, 15ASY0015, 15DSY0013, 15FSY0015, 15KSY0037 and 19 more |
| Model numbers | 71369310 |
Product
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, 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-1909-2017. 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.