—#82081

Product

Biomet Biolox-Delta Modular Ceramic Head, 28 mm head diameter, plus 5 neck, type 1, taper, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number 12-115112. A hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint.

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K042091
Affected lot / code info: Lots 114380, 175490, 229000, 310710, 342670, 385840, 403940, 467870, 484970, 572770, 641430, 705380, 761420 and 792280.

Why it was recalled

The firm has received reports of fractured heads, requiring revision surgery.

Root cause (FDA determination)

Process control

Action the firm took

Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 16, 2009 to users describing the affected device. Consignees were instructed to locate and discontinue use of the product and quarantine until a sales representative can arrange for removal. Consignees were also asked to complete and return the attached "Fax-Back Response Form" to Biomet at 1-574-372-1683. Further questions can be directed to Biomet Orthopedics at 1-800-348-9500.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- US including PR and states of AZ, AL, AR, CA, CO, FL, IL, IN, KY, KS, MA, MI, LA, NY, SD, GA, MN, PA, NJ, MD, MI, OH, ME, TX, WA, WI and VA and countries of Australia, Belgium, Canada, Costa Rica, Finland, Netherlands and South Wales.

Timeline

Recall initiated: 2009-03-16
Posted by FDA: 2009-07-14
Terminated: 2010-10-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82081. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.