—#80928

Product

Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument for use in conjunction with Zimmer TM-400 Trabecular Metal implants during spinal surgery. The Broach Handle threads onto various broaches and trial implants. The handle with these broaches or trials attached is used to prepare and measure a vertebral space to accept a TM-400 Trabecular Metal implant.

FDA product code: HTQ — Broach
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: All lots.

Why it was recalled

The broach handle may fracture at the threaded tip during use, which would result in surgical intervention to retrieve the broach or the trial as the threaded tip fragment prevents attachment of another handle to retrieve the device.

Root cause (FDA determination)

Device Design

Action the firm took

Distributors and user accounts were notified by "Urgent: Medical Device Recall" letter dated April 29, 2009. The letter described the affected product, reason for recall, health risks, and action for consignees. Distributors were instructed to retrieve the devices and to return them to Zimmer no later than May 13, 2009. This instrument recall will result in an inability to implant the associated devices until a new instrument becomes available. For questions or assistance about the recall please contact Zimmer Spine by calling 800-777-7505.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Nationwide, Austria, Australia, Belgium, Canada, Finland, Germany, Greece, Korea, South Africa, Sweden, Switzerland, Taiwan and the United Kingdom.

Timeline

Recall initiated: 2009-04-29
Posted by FDA: 2009-07-07
Terminated: 2010-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80928. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.