PlainRecalls
FDA Devices Moderate Class II Terminated

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 inte

Reported: October 10, 2012 Initiated: August 23, 2012 #Z-2485-2012

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

Details

Recalling Firm
Biomet, Inc.
Units Affected
268 units total
Distribution
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.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Biomet, Inc.. Units affected: 268 units total.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on October 10, 2012. Severity: Moderate. Recall number: Z-2485-2012.