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Terminated

Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740

FDA Recall Z-0446-06 · Posted 2006-01-26

Recalling FirmDepuy Mitek, a Johnson & Johnson Co.
Recall StatusTerminated
Product CodeMAI
Date Initiated2005-10-27
Date Terminated2006-05-02
Product Quantity19 boxes (5 pieces each)

Reason for Recall

The device may contain one strand of suture instead of two strands

Firm Action

DePuy Mitek initiated the recall to domestic accounts by letter on 10/27/05 and to J & J Affiliates by email.

Root Cause

Other

Distribution Pattern

CA, IA, FL, MI, MO, OR, TX Foreign:Australia, Brazil, Sweden

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041075FASTIN RC ANCHORDepuy Mitek, A Johnson & Johnson Company · 2004-11-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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