RENOVATION — Class II medical device recall Z-1915-2017
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-1915-2017 |
|---|---|
| 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 | 4,947 units |
| Reason classes | labeling, specification failure |
| Lot numbers | 07MSY0001, 08CSY0035, 08FSY0034, 08FSY0035, 08FSY0035A, 08LSY0013, 08MSY0017, 09BSY0023, 09BSY0026, 09BSY0026A, 09DSY0008, 09FSY0006, 09HSY0003, 09HSY0007, 09JSY0003, 10CSY0004, 10CSY0015, 10CSY0016, 10DSY0002, 10ESY0009, 10ESY0015, 10ESY0019, 11CSY0009, 11CSY0015, 11FSY0007, 11GSY0003, 11GSY0022, 11GSY0023, 11HSY0062, 11JSY0003, 11MSY0018, 12ASY0010, 12BSY0012, 12CSY0005, 12DSY0022, 12DSY0028, 12FSY0027, 12HSY0007, 12HSY0036, 12KSY0016 and 46 more |
| Model numbers | 71369212 |
Product
RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, 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-1915-2017. 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.