—#97748

Product

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.

FDA product code: KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device class: Class 3
Medical specialty: Orthopedic
Affected lot / code info: 419402, 419403, 419404 and 419405.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 immediately discontinue use of the T-Handle in the "OFF" position. Send back the current T-Handle as soon as they receive a replacement. Carefully follow the instructions on the enclosed "FAX Back Response Form." Fax a copy of the Response Form to 574-372-1683 prior to return of product. Use priority carrier for shipment. If the product has been further distributed, consignees must notify hospital personnel of this action, via the enclosed "Dear Bioment Customer" notice. This letter must be give to hospital personnel responsible for receiving recall notices. Consignees are charged with the location and return of these products. Consignees were instructed to confirm receipt of this notice by calling, 800-348-9500, ext. 3755 or 3983. For any questions call 574-371-3755 or 574-372-3983.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-01-28
Posted by FDA: 2011-03-07
Terminated: 2011-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97748. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.