Z-1594-2011

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

Name: Z-1594-2011 ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850, Biomet Orthopedics...
Creator: Biomet, Inc.
Published: 2011-01-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-01-28 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of 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... on 2011-01-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1594-2011
Status: Terminated
Initiated: 2011-01-28
Posted: 2011-03-07
Terminated: 2011-07-27
Recalling firm: Zimmer GmbH
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.
Product code: KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
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.
Root cause tag: design
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: 419402, 419403, 419404 and 419405.

Product code KWA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)