—#90699

Product

Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm left stem, Sterile, REF 11-104954, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral revision surgery.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K031693
Affected lot / code info: Lot Number: M597090.

Why it was recalled

The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep.

Root cause (FDA determination)

Process change control

Action the firm took

Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 10, 2010. The letter went to distributors and users of the recalled device. The letter instructed the consignees to locate the recalled product and return the product to the firm. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8:00 AM to 5:00 PM.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.

Timeline

Recall initiated: 2010-03-10
Posted by FDA: 2010-05-26
Terminated: 2010-10-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90699. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.