Biomet, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0527-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 9, 2012

Date Posted: December 26, 2012

Recall Number: Z-0527-2013

Event ID: 63725

Reason for Recall:

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

Status: Terminated

Product Quantity: 49

Code Information:

Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated