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.
This recall has been terminated (originally issued July 14, 2009).
- Company
- Biomet, Inc.
- Recall Initiated
- March 16, 2009
- Posted
- July 14, 2009
- Terminated
- October 6, 2010
- Recall Number
- Z-1613-2009
- Quantity
- 174
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The firm has received reports of fractured heads, requiring revision surgery.
Distribution
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.
Lot / Code Info
Lots 114380, 175490, 229000, 310710, 342670, 385840, 403940, 467870, 484970, 572770, 641430, 705380, 761420 and 792280.
Root Cause
Process control
Action Taken
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.