Z-1005-03

Profile 8 x 20 mm Cannulated Interference Screw Round Head Catalog Number: 230420

Name: Z-1005-03 Profile 8 x 20 mm Cannulated Interference Screw Round Head Catalog Number: 230420
Creator: Mitek Worldwide
Published: 2003-06-16
License: https://open.fda.gov/license/

Mitek Worldwide / initiated 2003-06-16 / Terminated / root cause: labeling and UDI

FDA source

Mitek Worldwide began a recall of Profile 8 x 20 mm Cannulated Interference Screw Round Head Catalog Number: 230420 on 2003-06-16. The reason FDA records is "Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 X 25mm". 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-1005-03
Status: Terminated
Initiated: 2003-06-16
Posted: 2003-07-15
Terminated: 2003-10-22
Recalling firm: Mitek Worldwide
Product: Profile 8 x 20 mm Cannulated Interference Screw Round Head Catalog Number: 230420
Reason for recall: Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 X 25mm
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Mitek notified consignees by letter on 6/16/0 by US Mail Certified Return Receipt. The international affiliates were notified by email on 6/16/03. Users were requested to return product in inventory.
Quantity in commerce: 40
Distribution: CA, FL, NJ, MO, NY, OR, TX, VA Foreign: Argentina, Australia, Japan, Arab Emirates, Portugal, spain
Product codes and lots: Lot Number: 0207146 Exp 2007-7

K982662Class IIDepuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference ScrewDePuy Orthopaedics, Inc. / cleared 1998-10-28

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)