Z-0907-03

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

Name: Z-0907-03 TransFx Pin, External Fixation Pin. 3.0 /4.0 mm x 80mm, 20mm thread
Creator: Immedica Inc
Published: 2003-02-10
License: https://open.fda.gov/license/

Immedica, Inc. / initiated 2003-02-10 / Terminated / root cause: labeling and UDI

FDA source

Immedica Inc began a recall of TransFx Pin, External Fixation Pin. 3.0 /4.0 mm x 80mm, 20mm thread on 2003-02-10. The reason FDA records is "Mislabeled; wrong identification number on pin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0907-03
Status: Terminated
Initiated: 2003-02-10
Posted: 2003-06-05
Terminated: 2003-10-09
Recalling firm: Immedica, Inc.
Product: TransFx Pin, External Fixation Pin. 3.0 /4.0 mm x 80mm, 20mm thread.
Product code: LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Reason for recall: Mislabeled; wrong identification number on pin.
Root cause tag: labeling and UDI
FDA 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 in commerce: 127
Distribution: The product is only distributed to Zimmers Patient Care Division, P.O. Box 569, Dover, OH 44622. There are no government accounts.
Product codes and lots: Catalog No./Part No./Ref.No. -- 00-4453-34-08. Lot Number: 70209800

Product code LXT

K990848Class IITransfx Intermediate External Fixation System,transfx Small External Fixation System, Transfx Mini External FixationImmedica, Inc. / cleared 1999-05-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)