RENOVATION — Class II medical device recall Z-1914-2017
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-1914-2017 |
|---|---|
| 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 | 8,067 units |
| Reason classes | labeling, specification failure |
| Lot numbers | 07AM06944, 07LSY0047, 07LSY0048, 08BSY0012, 08BSY0014B, 08BSY0016, 08FSY0051, 08JSY0012, 08JSY0033, 08KSY0015, 08KSY0018, 08LSY0011, 08LSY0044, 08LSY0044A, 08MSY0018, 09BSY0011, 09BSY0025, 09DSY0012, 09DSY0014, 09FSY0005, 09HSY0002, 09HSY0006, 09HSY0006A, 09JSY0002, 09JSY0005, 09JSY0006, 09JSY0007, 09JSY0008, 09JSY0009, 09KSY0002, 10CSY0003, 10CSY0013, 10CSY0014, 10ESY0012, 10ESY0017, 10GSY0006, 10HSY0007, 10MSY0007, 11150707, 11ASY0004 and 71 more |
| Model numbers | 71369210 |
Product
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, 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-1914-2017. 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.