FDA Medical Device Recalls (openFDA)
Synovis Surgical Inovation Div. of: Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,( PSD 21-E-V), 21mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip.
- Recall number
- Z-0960-2007
- Recalling firm
- Synovis Surgical Inovation Div. of
- Product
- Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,( PSD 21-E-V), 21mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip.
- Status
- Terminated
- Initiated
- 2007-03-16
- Posted
- 2007-06-15
- Terminated
- 2008-02-24
- Reason
- Package Integrity/Sterility Compromised: The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.
- Root cause
- Other
- Action
- Recall notification letters were sent to hospitals via Federal Express on 03/16/2007. This letter describes the product being recalled and problem. It requests consignees to complete and fax back the product return form. EXPANDED Another recall letter dated 04/23/2007 was sent to inform customers of 17 aditional lot numbers being recalled. A third recall letter dated 05/05/2007 was set to hospitals to inform them of one additional Lot/Serial number that was affected. This letter also requests a product return form be completed and faxed to Synovis Surgical Innovations.
- Quantity
- 1722
- Distribution
- Nationwide including states of AZ, CA, CT, FL, IA, IL, IN, KY, MA, MI, MN, MO, NJ, NY, OH, OK, PA, TN, TX, VA, and WI
- Lot, serial or model codes
- 5713042-221741, 5713423-227242, 5717696-316474, 5717892-318414, 5718084-321564, 5718811-335330, 5718931-337921, 5719156-342542, 5717892-408336, 5718084-408339, 5719536-348390, 5721731-391016, 5721732-391017, 5721988-395784, 5722089-397032, 5725033-478976, 5725482-487062, 5725665-491224, 5725782-495452, 5726120-498547, 5727333-525321, 5721988-540345, 5727334-525322. EXPANDED LOT/SERIAL #'s: 5728409-544891, 5729325-562207, 5727334-560764.
- 510(k) numbers
- ["K041669"]
- PMA numbers
- not on file
- Product code
- FTM
- Firm FEI
- 2183620
- Firm city
- Saint Paul
- Firm state
- MN
- 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