Radial Osteotome Blade — Class II medical device recall Z-0406-2018
Terminated recall by Smith & Nephew, Inc., reported 2018-01-31, distributed in NJ, TN. The expiration date provided on the label is incorrect.
| Recall number | Z-0406-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2017-10-23 |
| Classified | 2018-01-24 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2018-08-24 |
| Distributed | NJ, TN |
| Countries outside the US | AU |
| Quantity | 9 units |
| Reason classes | labeling |
| Lot numbers | 09FSY0003R, 12HSY0040R, 14HSY0006R, 15KSY0023R, 15MSY0005R |
| Model numbers | 71369314 |
Product
Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
Reason for recall
The expiration date provided on the label is incorrect.
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-0406-2018. 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.