RENOVATION — Class II medical device recall Z-1918-2017
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-1918-2017 |
|---|---|
| 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 | 4,033 units |
| Reason classes | labeling, specification failure |
| Lot numbers | 07MSY0025, 08CSY0040, 08FSY0036, 08JSY0001, 08JSY0010, 08JSY0010A, 08JSY0031, 08JSY0031A, 08KSY0009, 08LSY0005, 08LSY0021, 08LSY0022, 08MSY0004, 09BSY0028, 09HSY0009, 10CSY0010, 10CSY0021, 10CSY0022, 10ESY0010, 10ESY0018, 10KSY0034, 11CSY0010, 11DSY0005, 11DSY0013, 11DSY0050, 11ESY0009, 11FSY0005, 11GSY0008, 11GSY0027, 11HSY0011, 11HSY0059, 11JSY0005, 12ASY0015, 12BSY0016, 12DSY0017, 12ESY0002, 12FSY0004, 12GSY0031, 12HSY0027, 12HSY0043 and 47 more |
| Model numbers | 71369410 |
Product
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, 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-1918-2017. 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.