Zimmer Inc. 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 a Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 a
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
Lots 52987100, 53024600, 56454682, 56454683, 5645684, 70185500, 70196100, 70203500, 70211400, 70216000, 70244300 and 70244400.
Products Sold
Lots 52987100, 53024600, 56454682, 56454683, 5645684, 70185500, 70196100, 70203500, 70211400, 70216000, 70244300 and 70244400.
Zimmer Inc. is recalling TransFx External Fixation System Drill Bit, Quick Connect, 2.0 mm diameter, 125 mm length, nonsteril due to Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during o. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026