—#115921

Product

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number 5313152 Lot 153880,153930, 415500, 648010

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2013-02-05
Posted by FDA: 2013-03-08
Terminated: 2013-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115921. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.