Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.

FDA Recall Z-2485-2012 · Posted 2012-09-28

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHXX
Date Initiated2012-08-23
Date Terminated2013-08-27
Product Quantity268 units total

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

Firm Action

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

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑