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Terminated

Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101

FDA Recall Z-0656-2010 · Posted 2010-01-19

Recalling FirmTAG Medical Corp.
Recall StatusTerminated
Product CodeNBH
Date Initiated2009-12-04
Date Terminated2016-02-29
Product Quantity60 UNITS

Reason for Recall

Device failed to deploy the distal loop

Firm Action

Medicsense, the US Agent notified the sole distributor Tornier Inc., Edina, MN of the recall and requested notification to users requesting to discontinue and return product. Letter to customers dated December 4, 2009.

Root Cause

Process change control

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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