ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850, Biomet Orthopedics Warsaw, IN. Th

FDA device recall Z-1594-2011 · posted 2011-03-07 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KWA

Quantity affected

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.

Date initiated

2011-01-28

Date posted

2011-03-07

Date terminated

2011-07-27

Location

Warsaw, IN