Recall Z-1538-2009
Zimmer Inc. · initiated May 1, 2009
Product
TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 230 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-67. 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.
Codes / lots: Lots 53012100, 53012200, 53022800, 53023100, 56023500, 70186300, 70239200 and 70247800.
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1538-2009
- Initiated
- May 1, 2009
- Posted by FDA
- June 30, 2009
- Terminated
- November 3, 2010
- Product code
- LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Quantity
- 547
- Distribution
- Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.
- Recalling firm
- Zimmer Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1532-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 2.0 mm diameter, 125 mm…Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and… | 05/01/2009Terminated |
| Z-1533-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 2.5 mm diameter, 180 mm…Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and… | 05/01/2009Terminated |
| Z-1534-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 3.0 mm diameter, 180 mm…Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and… | 05/01/2009Terminated |
| Z-1535-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm…Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and… | 05/01/2009Terminated |
| Z-1536-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 195 mm…Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and… | 05/01/2009Terminated |
| Z-1537-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 4.5 mm diameter, 230 mm…Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and… | 05/01/2009Terminated |