Recall Z-0093-2011

Codman & Shurtleff, Inc. · initiated July 16, 2010

Terminated

Product

Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396

Codes / lots: Lot numbers: EB515 GB501 HB489 KB431 KB431 KB529 KB529 LB412 LB436 LB437 421412 422509 423818 423819 423820

Reason for recall

Surgical Pattie x-ray stripe (radio-opaque marker) became detached

FDA-determined cause: Process control

Action taken

Codman notified customers by letter dated 7/16/10 issued July 23 through July 26, 2010 via Fed'x overnight advising users that the x-ray marker on Codman Surgical Patties may become detached. Customers are instructed to return product from affected lots. An error in the original letter was discovered and a corrected letter dated July 28, 2010 issued. If there are any questions, please contact Codman at (800) 225-0460.

Details

Recall number
Z-0093-2011
Initiated
July 16, 2010
Posted by FDA
October 20, 2010
Terminated
July 9, 2012
Product code
HBA – Neurosurgical Paddie
Quantity
673 boxes (20 pouches of 10 patties per box)
Distribution
Nationwide Foreign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore,
Recalling firm
Codman & Shurtleff, Inc., Raynham, MA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0094-2011 Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code:…Surgical Pattie x-ray stripe (radio-opaque marker) became detached 07/16/2010Terminated
Z-0095-2011 Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties…Surgical Pattie x-ray stripe (radio-opaque marker) may become detached 07/16/2010Terminated