—#81653

Product

TransFx External Fixation System Drill Bit, Quick Connect, 2.0 mm diameter, 125 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-54. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.

FDA product code: LXT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K003205, K984357, K990848, K991723
Affected lot / code info: Lots 52987100, 53024600, 56454682, 56454683, 5645684, 70185500, 70196100, 70203500, 70211400, 70216000, 70244300 and 70244400.

Why it was recalled

Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.

Root cause (FDA determination)

Process control

Action the firm took

Distributors and consignees were notified by an Urgent: Device Recall letter dated 5/1/09. Consignees were advised to stop using the device and quarantine it immediately. Distributors were instructed to carry out a physical count of all affected product and record the data on the Inventory Return Certification Form; fax a copy of the completed form to Zimmer, Inc.; and return recalled product along with the Inventory Return Certification Form to the firm.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.

Timeline

Recall initiated: 2009-05-01
Posted by FDA: 2009-06-30
Terminated: 2010-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81653. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.