Z-0446-06

Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture...

Name: Z-0446-06 Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture...
Creator: Depuy Mitek, a Johnson & Johnson Co.
Published: 2005-10-27
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2005-10-27 / Terminated

FDA source

Depuy Mitek, a Johnson & Johnson Co. began a recall of Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740 on 2005-10-27. The reason FDA records is "The device may contain one strand of suture instead of two strands". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0446-06
Status: Terminated
Initiated: 2005-10-27
Posted: 2006-01-26
Terminated: 2006-05-02
Recalling firm: DePuy Mitek, Inc.
Product: Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740
Product code: MAI Fastener, Fixation, Biodegradable, Soft Tissue
Reason for recall: The device may contain one strand of suture instead of two strands
FDA root cause: Other
Action: DePuy Mitek initiated the recall to domestic accounts by letter on 10/27/05 and to J & J Affiliates by email.
Quantity in commerce: 19 boxes (5 pieces each)
Distribution: CA, IA, FL, MI, MO, OR, TX Foreign:Australia, Brazil, Sweden
Product codes and lots: Lot Number:1270449

Product code MAI

K041075Class IIFastin Rc AnchorDepuy Mitek, A Johnson & Johnson Company / cleared 2004-11-09

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)