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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-0094-2011
Recall Event ID 56279
510(K)NumberK880402 
Product Classification Neurosurgical Paddie - Product Code HBA
ProductCodman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
Code Information Lot numbers:  EB514  FB465 GB498  GB449  HB544  HB545  KB438  KB538  KB436  KB527  LB554  LlB555  AC464  421417 421418 421419 422512 423826 423076 423827 423828 423829 423830 423075 HB499   
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 Commerce 4407 boxes (20 pouches of 10 patties)
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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