Recall Z-1533-2009 ยท LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Zimmer Inc.
TransFx External Fixation System Drill Bit, Quick Connect, 2.5 mm diameter, 180 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-56. 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-drillin
| Date | Jun 30, 2009 (initiated May 1, 2009) |
| Status | Terminated |
| 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 | 1391 |
| Distribution | Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003205 | TRANSFX ANGLED RODS Immedica, Inc., Dec 15, 2000 |
| K984357 | TRANSFX EXTERNAL FIXATION SYSTEM Immedica, Inc., Mar 4, 1999 |
| K990848 | TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION Immedica, Inc., May 17, 1999 |
| K991723 | TRANSFX MULTI PIN CLAMP Immedica, Inc., Jul 22, 1999 |