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Terminated

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

FDA Recall Z-0907-03 · Posted 2003-06-05

Recalling FirmImmedica Inc
Recall StatusTerminated
Product CodeLXT
Date Initiated2003-02-10
Date Terminated2003-10-09
Product Quantity127

Reason for Recall

Mislabeled; wrong identification number on pin.

Firm 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.

Root Cause

Other

Distribution Pattern

The product is only distributed to Zimmers Patient Care Division, P.O. Box 569, Dover, OH 44622. There are no government accounts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990848TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATIONImmedica, Inc. · 1999-05-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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