Z-0699-03

Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head Product Reference No.: 230420

Name: Z-0699-03 Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head Product Reference No.: 230420
Creator: Mitek Worldwide
Published: 2003-02-28
License: https://open.fda.gov/license/

Mitek Worldwide / initiated 2003-02-28 / Terminated / root cause: labeling and UDI

FDA source

Mitek Worldwide began a recall of Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head Product Reference No.: 230420 on 2003-02-28. The reason FDA records is "Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 20 mm". 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-0699-03
Status: Terminated
Initiated: 2003-02-28
Posted: 2003-04-01
Terminated: 2004-02-04
Recalling firm: Mitek Worldwide
Product: Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head Product Reference No.: 230420
Product code: HWC Screw, Fixation, Bone
Reason for recall: Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 20 mm
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Mitek Worldwide notified domestic accounts by US Mail on 2/28/03. The International affiliates were sent notifications by Federal Express on 2/28/03.
Quantity in commerce: 20
Distribution: CO, FL, MN, PA, TX International- Mitek Affiliates: Australia, Columbia, Japan UK,
Product codes and lots: Lot Number: 0301594

Product code HWC

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

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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)