RENOVATION — Class II medical device recall Z-1919-2017
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-1919-2017 |
|---|---|
| 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 | 1,741 units |
| Reason classes | labeling, specification failure |
| Lot numbers | 07LSY0011, 07LSY0035, 07LSY0038, 07LSY0040, 08GSY0007, 08GSY0007A, 08GSY0008, 08MSY0015, 09BSY0029, 10CSY0011, 10CSY0023, 10ESY0011, 11DSY0006, 11DSY0011, 11ESY0010, 11HSY0012, 11HSY0061, 11JSY0007, 12BSY0015, 12DSY0018, 12DSY0030, 12FSY0003, 12GSY0030, 12HSY0028, 12HSY0044, 12LSY0022, 12MSY0007, 12MSY0015, 13BSY0010, 13BSY0013, 13BSY0018, 13BSY0035, 13KSY0015, 13MSY0008, 14ASY0035, 14CSY0009, 14CSY0042, 14KSY0033, 14LSY0014, 15BSY0011 and 23 more |
| Model numbers | 71369412 |
Product
RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, 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-1919-2017. 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.