—#114639

Product

EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.

FDA product code: KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K000083
Affected lot / code info: Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)

Why it was recalled

It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.

Root cause (FDA determination)

Process design

Action the firm took

On 11/9/2012 an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to all consignees (distributors and Doctor notices) informing them of the issue and providing recommended actions. Customer contact number (574) 372-1570 Monday through Friday from 8 am to 5 pm.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.

Timeline

Recall initiated: 2012-11-09
Posted by FDA: 2012-12-17
Terminated: 2013-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114639. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.