Biosure Driver — Class II medical device recall Z-0699-2016
Terminated recall by Smith & Nephew, Inc., Endoscopy Div., reported 2016-02-10, distributed in AK, AL, CA, CO, FL, IL, IN, MI…. Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or
| Recall number | Z-0699-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA, United States |
| Recall initiated | 2013-04-04 |
| Classified | 2016-01-29 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2021-03-22 |
| Distributed | AK, AL, CA, CO, FL, IL, IN, MI, NE, NJ, NY, OH, OK, PA, SC, TN, TX |
| Countries outside the US | AT, AU, CA, CH, GB, IN, IT, KR, MY, NL, PT, SE, SG, ZA |
| Quantity | 157 |
| Lot numbers | 50399964, 50404149, 50409038 |
Product
Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
Reason for recall
Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
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-0699-2016. 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.