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U.S. Department of Health and Human Services

Class 2 Device Recall Codman

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 Class 2 Device Recall Codmansee related information
Date Initiated by FirmJuly 16, 2010
Date PostedOctober 20, 2010
Recall Status1 Terminated 3 on July 09, 2012
Recall NumberZ-0093-2011
Recall Event ID 56279
510(K)NumberK880402 
Product Classification Neurosurgical Paddie - Product Code HBA
ProductCodman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396
Code Information Lot numbers:  EB515  GB501 HB489  KB431  KB431  KB529  KB529  LB412  LB436  LB437  421412 422509 423818 423819 423820  
FEI Number 3002947440
Recalling Firm/
Manufacturer		 Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham MA 02767
For Additional Information ContactSame
508-828-3532
Manufacturer Reason
for Recall		Surgical Pattie x-ray stripe (radio-opaque marker) became detached
FDA Determined
Cause 2		Process control
ActionCodman 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.
Quantity in Commerce673 boxes (20 pouches of 10 patties per box)
DistributionNationwide Foreign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore,
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HBA
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