TAG Medical Corp. Kibbutz Gaaton Naharia Israel Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101
Brand
TAG Medical Corp. Kibbutz Gaaton Naharia Israel
Lot Codes / Batch Numbers
Lot Numbers: 09K1, 09J5, 09J6, 09K3, 09K4, & 09K5
Products Sold
Lot Numbers: 09K1, 09J5, 09J6, 09K3, 09K4, & 09K5
TAG Medical Corp. Kibbutz Gaaton Naharia Israel is recalling Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalo due to Device failed to deploy the distal loop. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device failed to deploy the distal loop
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026