Atlas FDA

TransFx Pin, External Fixation Pin. 3.0 /4.0 mm x 80mm, 20mm thread.

FDA device recall Z-0907-03 · posted 2003-06-05 · Terminated

Recall details

Recalling firm
Immedica Inc
Reason for recall
Mislabeled; wrong identification number on pin.
Action taken
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.
Root cause
Other
Status
Terminated
Product code
LXT
Quantity affected
127
Distribution
The product is only distributed to Zimmers Patient Care Division, P.O. Box 569, Dover, OH 44622. There are no government accounts.
Date initiated
2003-02-10
Date posted
2003-06-05
Date terminated
2003-10-09
Location
Chatham, NJ

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION (K990848)Immedica, Inc.1999-05-17