Recall Z-1594-2011 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Biomet, Inc.
ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850, Biomet Orthopedics Warsaw, IN. The torque limiting T-handle is used with attachments and hex drivers for preparation of the femur and for locking screw insertion at specified torque limit in Arcos hip procedures.
| Date | Mar 7, 2011 (initiated Jan 28, 2011) |
| Status | Terminated |
| Reason | The firm received two complaints of the tabs on the Torque Limiting T-Handle fracturing during surgery. The firm performed internal testing and found that the tabs may fracture when used in the "OFF" or "locked" setting for hand-reaming the femoral canal. |
| Root cause | Device Design |
| Action | Biomet, Inc. made telephone calls to distributor accounts on January 28, 2011, with specific instructions that the Arcos Torque Limiting T-Handle was not to be used in the "OFF" position. Distributors were required to use the Arcos Torque Limiting T-Handle on the "55" setting for insertion of locking screws and troch bolt. Biomet, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTICE letter dated February 21, 2011, to their distributors. The letter stated that the firm was currently manufacturing replacement handles which would be distributed to the field shortly. Consignees were advised to |
| Quantity | 40 units |
| Distribution | Worldwide Distribution - USA including the states of CA, NY, FL, VA, UT, IL, MI, KY, OH, MA, PA, SD, MO, TX, NV, Puerto Rico, and the countries of Australia, New Zealand, Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.