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Terminated

TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-61. 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 Recall Z-1535-2009 · Posted 2009-06-30

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLXT
Date Initiated2009-05-01
Date Terminated2010-11-03
Product Quantity83

Reason for Recall

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

Firm Action

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.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003205TRANSFX ANGLED RODSImmedica, Inc. · 2000-12-15K991723TRANSFX MULTI PIN CLAMPImmedica, Inc. · 1999-07-22K990848TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATIONImmedica, Inc. · 1999-05-17K984357TRANSFX EXTERNAL FIXATION SYSTEMImmedica, Inc. · 1999-03-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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