Z-0656-2010

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

Name: Z-0656-2010 Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number...
Creator: TAG Medical Corp.
Published: 2009-12-04
License: https://open.fda.gov/license/

T.A.G. Medical Products Corporation Ltd / initiated 2009-12-04 / Terminated

FDA source

TAG Medical Corp. began a recall of Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101 on 2009-12-04. The reason FDA records is "Device failed to deploy the distal loop". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0656-2010
Status: Terminated
Initiated: 2009-12-04
Posted: 2010-01-19
Terminated: 2016-02-29
Recalling firm: T.A.G. Medical Products Corporation Ltd
Product: Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101
Product code: NBH Accessories, Arthroscopic
Reason for recall: Device failed to deploy the distal loop
FDA root cause: Process change control
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.
Quantity in commerce: 60 UNITS
Distribution: Nationwide
Product codes and lots: Lot Numbers: 09K1, 09J5, 09J6, 09K3, 09K4, & 09K5

Product code NBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)