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Terminated

Depuy Mitek Bioknotless Anchor with Ethibond Suture Ref No. 212728

FDA Recall Z-0610-06 · Posted 2006-03-15

Recalling FirmDepuy Mitek, a Johnson & Johnson Co.
Recall StatusTerminated
Product CodeMAI
Date Initiated2006-02-17
Date Terminated2006-06-28
Product Quantity200 pieces

Reason for Recall

The inserter shafts bend, as they were manufactured with a different stainless steel than specified.

Firm Action

Depuy Mitek notified consignees by letter dated 2/17/06 to request accounts return devices.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002639BIOKNOTLESS ANCHORMitek Products · 2001-05-11

Official Source

View FDA Recall →

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

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