FDA Medical Device Recalls (openFDA)
Covidien LP: Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.
- Recall number
- Z-1157-2010
- Recalling firm
- Covidien LP
- Product
- Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.
- Status
- Terminated
- Initiated
- 2010-02-08
- Posted
- 2010-03-16
- Terminated
- 2013-02-28
- Reason
- Fixation device may fail to fire and staple.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 5,638 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Batch Number: P9M0113, P9M0312, P9M0515, P9M0516, P9M0647, P9M0696, P9M0771, P9M0816. Expanded Recall 6/23/10: P9H1081, P9M0113, P0A0021,P0A0723, P0B0753
- 510(k) numbers
- ["K090470","K963999"]
- PMA numbers
- not on file
- Product code
- GDW
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28