RENOVATION — Class II medical device recall Z-1916-2017
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-1916-2017 |
|---|---|
| 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 | 2,017 units |
| Reason classes | labeling, specification failure |
| Lot numbers | 07MSY0006, 07MSY0011, 07MSY0011A, 08CSY0037, 08CSY0042, 08ESY0082, 08FSY0037, 08FSY0037B, 08FSY0037C, 08JSY0008, 08LSY0014, 09BSY0012, 09JSY0010, 09JSY0011, 09JSY0012, 10CSY0005, 10CSY0017, 10CSY0018, 10KSY0033, 11GSY0004, 11GSY0024, 11JSY0009, 11KSY0068, 11MSY0019, 12ASY0011, 12BSY0013, 12DSY0015, 12DSY0029, 12FSY0006, 12FSY0030, 12HSY0023, 12HSY0037, 12KSY0023, 12LSY0019, 12MSY0004, 12MSY0018, 13BSY0007, 13BSY0014, 13BSY0041, 13FSY0017 and 36 more |
| Model numbers | 71369220 |
Product
RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, 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-1916-2017. 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.