Recalls / —

—#67988

Product

Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem Inserter, Part number: 31-555610.

FDA product code

LXH — Orthopedic Manual Surgical Instrument

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

Lots 218606, 218614 and 217595.

Why it was recalled

The instrument will not mate with its stem.

Root cause (FDA determination)

Process control

Action the firm took

Biomet distributors were notified via recall letter dated 2/12/08 to locate the instruments in their possession and at hospital sites and to return them to Biomet. Hospitals with the instruments on hand will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2008-02-12

Posted by FDA

2008-09-11

Terminated

2009-06-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #67988. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.