RENOVATION — Class II medical device recall Z-1920-2017
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-1920-2017 |
|---|---|
| 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 | 742 units |
| Reason classes | labeling, specification failure |
| Lot numbers | 07LSY0034, 07LSY0041, 07MSY0013, 08FSY0052, 08LSY0020, 08LSY0020A, 08LSY0042, 08MSY0020, 09BSY0030, 11DSY0007, 11ESY0011, 11FSY0006, 11HSY0013, 11HSY0060, 11JSY0008, 11JSY0019, 12KSY0027, 12MSY0008, 12MSY0016, 13BSY0036, 13FSY0026, 13KSY0016, 14GSY0013, 14KSY0005, 15ASY0020, 15ESY0015, 15JSY0009, 15MSY0009, 16ESY0079, 431604, 431612, 431614, 4500032273, 467087, 469005, 472361, 477931, 477931A, 477931B, 477931C and 8 more |
| Model numbers | 71369420 |
Product
RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, 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-1920-2017. 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.