REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument

FDA device recall Z-0925-2013 · posted 2013-03-08 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes.

Action taken

BIOMET sent an Urgent Recall Notice beginning February 13, 2013, to all affected customers. The notice included possible adverse events and directions to locate and remove identified devices by returning a Fax Back Response Form to 574-372-1683 and obtaining an RGA # prior to return of product to Biomet, Inc. 56 East Bell Drive Warsaw, IN 46580. Questions should be directed to 574 372-1570 M-F, 8 a.m.-5.p.m. For questions regarding this recall call 574-267-6639, ext 1676.

Root cause

Process control

Status

Terminated

Product code

LXH

Quantity affected

58

Distribution

Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile

Date initiated

2013-02-05

Date posted

2013-03-08

Date terminated

2013-09-30

Location

Warsaw, IN