Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fr

FDA device recall Z-2486-2012 · posted 2012-09-28 · Terminated

Recall details

Recalling firm

Biomet, Inc.

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

Action taken

Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE'' dated August 23, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. A Fax Back Response Form was included for customers to complete and return via fax to 574-372-1683. Contact the firm at 574-372-1570 for questions related to this recall.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

HXX

Quantity affected

363 units

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 Japa

Date initiated

2012-08-23

Date posted

2012-09-28

Date terminated

2013-08-27

Location

Warsaw, IN