Z-2485-2012 Class II Terminated
FDA device recall Z-2485-2012 was initiated by Biomet, Inc. on Aug 23, 2012 and is designated Class II. 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)… The recall status is terminated (terminated Aug 27, 2013). Affected quantity: 268 units total.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 10, 2012
- Initiation Date
- Aug 23, 2012
- Termination Date
- Aug 27, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 268 units total
Product Description
Optilock 2.7 mm Screw Inserter. 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
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of AL, GA, MT, TA, AZ, WA, CA, TA, IN, NY, NJ, VA, MA, MI, MD, PA, KY, NC, UT, NH, FL, OK, CO, LA, OH, MO and SD, and the countries of Japan, Netherlands, Australia, and Costa Rica.
Code Information
Catalog number: 14-400795; and lot numbers: 133420, 409460, 469960, 487650, 487660, 627940, 627950, 797190, and 797200.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2485-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026