Z-0611-06

Depuy Mitek Bioknotless Anchor with Panacryl Suture Ref No. 212729

Name: Z-0611-06 Depuy Mitek Bioknotless Anchor with Panacryl Suture Ref No. 212729
Creator: Depuy Mitek, a Johnson & Johnson Co.
Published: 2006-02-17
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2006-02-17 / Terminated / root cause: manufacturing process

FDA source

Depuy Mitek, a Johnson & Johnson Co. began a recall of Depuy Mitek Bioknotless Anchor with Panacryl Suture Ref No. 212729 on 2006-02-17. The reason FDA records is "The inserter shafts bend, as they were manufactured with a different stainless steel than specified". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0611-06
Status: Terminated
Initiated: 2006-02-17
Posted: 2006-03-15
Terminated: 2006-06-28
Recalling firm: DePuy Mitek, Inc.
Product: Depuy Mitek Bioknotless Anchor with Panacryl Suture Ref No. 212729
Product code: MAI Fastener, Fixation, Biodegradable, Soft Tissue
Reason for recall: The inserter shafts bend, as they were manufactured with a different stainless steel than specified.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Depuy Mitek notified consignees by letter dated 2/17/06 to request accounts return devices.
Quantity in commerce: 200 pieces
Distribution: Nationwide
Product codes and lots: Lot Number: 1359592 Exp. date Nov 2008

Product code MAI

K002639Class IIBioknotless AnchorMitek Products / cleared 2001-05-11

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)