Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number: RD115112. 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 Recall Z-1614-2009 · Posted 2009-07-14
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLZO
Date Initiated2009-03-16
Date Terminated2010-10-06
Product Quantity161
Reason for Recall
The firm has received reports of fractured heads, requiring revision surgery.
Firm Action
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.
Root Cause
Process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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