Z-1535-2009

TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm length, nonsterile...

Name: Z-1535-2009 TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm length, nonsterile...
Creator: Zimmer Inc.
Published: 2009-05-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-05-01 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of 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... on 2009-05-01. The reason FDA records is "Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1535-2009
Status: Terminated
Initiated: 2009-05-01
Posted: 2009-06-30
Terminated: 2010-11-03
Recalling firm: Zimmer GmbH
Product: 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.
Product code: LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 83
Distribution: Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.
Product codes and lots: Lots 56454675, 70185900, 70238100,70247500 and 70249700.

Product code LXT

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)