FDA Medical Device Recalls (openFDA)
Zimmer Inc.: TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-63. 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.
- Recall number
- Z-1536-2009
- Recalling firm
- Zimmer Inc.
- Product
- TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-63. 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.
- Status
- Terminated
- Initiated
- 2009-05-01
- Posted
- 2009-06-30
- Terminated
- 2010-11-03
- Reason
- 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
- 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
- 2146
- Distribution
- Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.
- Lot, serial or model codes
- Lots 53007700, 53022100, 53022200, 56454692, 56454693, 56454694, 56454695, 56454696, 56454697, 56454698, 70186000, 70193000, 70205400, 70247600, 70247700 and 70254400.
- 510(k) numbers
- ["K003205","K984357","K990848","K991723"]
- PMA numbers
- not on file
- Product code
- LXT
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28