RENOVATION — Class II medical device recall Z-1917-2017
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-1917-2017 |
|---|---|
| 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 | 3,748 units |
| Reason classes | labeling, specification failure |
| Lot numbers | 07LSY0010, 08BSY0013, 08BSY0015, 08FSY0032, 08FSY0033, 08FSY0033A, 08JSY0013, 08LSY0009, 09BSY0015, 09FSY0007, 09HSY0004, 09HSY0008, 09JSY0004, 09JSY0004A, 10CSY0009, 10CSY0009A, 10CSY0019, 10CSY0020, 10ESY0016, 10HSY0005, 10KSY0008, 11ASY0011, 11BSY0006, 11DSY0004, 11DSY0014, 11DSY0049, 11ESY0008, 11FSY0010, 11GSY0007, 11HSY0010, 11JSY0004, 11JSY0012, 11MSY0022, 12ASY0014, 12BSY0019, 12CSY0001, 12CSY0007, 12DSY0016, 12ESY0001, 12FSY0028 and 56 more |
| Model numbers | 71369408 |
Product
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, 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-1917-2017. 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.