Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling reads in part as follows: REF: 01-0264, QTY,UOM 00001, BY

FDA device recall Z-0169-2010 · posted 2009-11-10 · Terminated

Recall details

Recalling firm

Biomet Microfixation, Inc.

Reason for recall

Byrd Screw, Self Drilling, may break during usage. BIOMET has determined that the parts were not correctly processed by the vendor , i.e. that the parts were not hardened in the final processing and that lead to weaker than acceptable material.

Action taken

Biomet plans to send letters to customers on February 19, 2009. Customers are told to discontinue use of the item and return it to Biomet Microfixation. The firm plans to follow up with an e-mail to their customers. Questions pertaining to this issue, should be directed to Christy Cain at 1.800.874.7711 or 904.741.4400.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LXH

Quantity affected

22

Distribution

AZ, CA, GA, IL, IN, NM, NY, TX, VA, Puerto Rico and Canada.

Date initiated

2009-02-19

Date posted

2009-11-10

Date terminated

2012-05-03

Location

Jacksonville, FL