Recall Z-1613-2009 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Biomet, Inc.
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.
| Date | Jul 14, 2009 (initiated Mar 16, 2009) |
| Status | Terminated |
| Reason | The firm has received reports of fractured heads, requiring revision surgery. |
| Root cause | Process control |
| 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. |
| Quantity | 174 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042091 | BIOLOX DELTA CERAMIC HEADS Biomet, Inc., Mar 25, 2005 |