510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0960-2007

Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,( PSD 21-E-V), 21mm...

SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) / initiated 2007-03-16 / Terminated / root cause: packaging
FDA source (opens on fda.gov)

Synovis Surgical Inovation Div. of began a recall of Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,( PSD 21-E-V), 21mm, Ethicon Circular stapler. Each package contains... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-0960-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)
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.
Product code
FTM Mesh, Surgical
Reason for recall
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 tag
packaging
FDA 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 in commerce
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
Product codes and lots
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.