Optilock T15 AO Driver — Class II medical device recall Z-2486-2012
Terminated recall by Biomet, Inc., reported 2012-10-10, distributed nationwide. Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock
| Recall number | Z-2486-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-08-23 |
| Classified | 2012-09-28 |
| Reported by FDA | 2012-10-10 |
| Terminated | 2013-08-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CR, JP, NL |
| Quantity | 363 units |
| Lot numbers | 069540, 179190, 201610, 385380, 419940, 427530, 440360, 440370, 555370, 638560, 645820, 956960 |
| Model numbers | 36505 |
Product
Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.
Reason for recall
Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are misshapen may not properly mate with screws at MMC. Design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screw
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-2486-2012. 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.