Auto Suture ProTack Fixation 5 mm recallZ-1157-2010 · Covidien LP · initiated Feb 8, 2010
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Fixation device may fail to fire and staple.
FDA root cause category: Process control
What the company is doing
Covidien notified accounts by "Urgent Medical Device Recall" letters dated 2/8/10. The letter identified the affected product and the reason for recall. Customers are to examine their inventory, and remove and return recalled lots. Customers are to follow the instructions provided in the letter to return the affected product. Questions should be directed to a Covidien Representative. On June 23, 2010, the firm issued a letter to expand the recall to include 5 additional lots.
Recall details
- Recall number
- Z-1157-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 8, 2010
- Posted by the FDA
- Mar 16, 2010
- Recalling firm
- Covidien LP
- Quantity
- 5,638 units
- Product code
- GDW
- FDA submissions
- K090470, K963999
- Distribution
- Nationwide Distribution
Product description
Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.
Code information (models, lots, serial numbers)
Batch Number: P9M0113, P9M0312, P9M0515, P9M0516, P9M0647, P9M0696, P9M0771, P9M0816. Expanded Recall 6/23/10: P9H1081, P9M0113, P0A0021,P0A0723, P0B0753
Other devices under the same FDA submission
5 devices cleared under K090470, K963999 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ProTack 174006Covidien LP · Endoscopic tissue approximation device709 reports
- Stat Tack OMS-TTSSCovidien LP · STAPLE, IMPLANTABLE12 reports
- Tacker OMS-TTSDCovidien LP · STAPLE, IMPLANTABLE3 reports
- Tacker OMS-TTSD30Covidien LP · STAPLE, IMPLANTABLE3 reports
- Tacker OMS-TTHCovidien LP · STAPLE, IMPLANTABLE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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