Z-1304-04

Achillon minimally invasive Achilles tendon suture system

Name: Z-1304-04 Achillon minimally invasive Achilles tendon suture system
Creator: Wright Medical Technology Inc
Published: 2004-07-02
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2004-07-02 / Terminated / root cause: sterility

FDA source

Wright Medical Technology Inc began a recall of Achillon minimally invasive Achilles tendon suture system on 2004-07-02. The reason FDA records is "Lack of sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1304-04
Status: Terminated
Initiated: 2004-07-02
Posted: 2004-07-31
Terminated: 2005-07-05
Recalling firm: Wright Medical Technology Inc
Product: Achillon minimally invasive Achilles tendon suture system
Product code: MCZ Suture Removal Kit
Reason for recall: Lack of sterility assurance
Root cause tag: sterility
FDA root cause: Other
Action: Wright Medical Technology notified its consignees via email and telephone to ensure that the email was received. The consignees asked to return any in-stock recalled product to Wright Medical Technology.
Quantity in commerce: 20 units
Distribution: Nationwide
Product codes and lots: Product: Achillon Reference No.: 119 700 Batch No.: C Sterilization Batch No.: S037

Product code MCZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)