—#52988

Product

Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38)

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lots 824920, 559080, 509420, 493210, 221060, 167220 and 129030. .

Why it was recalled

The instrument was manufactured incorrectly and use could result in the instrument binding to the acetabular component and cause implant to not release following inpaction.

Root cause (FDA determination)

Other

Action the firm took

On 6/13/07, the firm sent a Urgent Medica Device Correction Notice to its sales force instructing them to retrieve affected units from their hospital accounts and to return them to the firm. International accounts were notified via email on 6/14/07.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46581-0587

Distribution

Distribution pattern: World wide: USA, Australia, and Finland.

Timeline

Recall initiated: 2007-06-14
Posted by FDA: 2007-08-07
Terminated: 2007-12-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52988. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.