Recall Z-0907-03 ยท LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Immedica Inc
TransFx Pin, External Fixation Pin. 3.0 /4.0 mm x 80mm, 20mm thread.
| Date | Jun 5, 2003 (initiated Feb 10, 2003) |
| Status | Terminated |
| Reason | Mislabeled; wrong identification number on pin. |
| Root cause | Other |
| Action | Recall letter was sent on 2/10/2003 to Zimmer Patient Care Division. The letter states that Zimmer is to conduct a sub-recall to their customers to account for the 127 pieces sent to them. |
| Quantity | 127 |
| Distribution | The product is only distributed to Zimmers Patient Care Division, P.O. Box 569, Dover, OH 44622. There are no government accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990848 | TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION Immedica, Inc., May 17, 1999 |