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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 Codman see related information
Date Initiated by Firm July 16, 2010
Date Posted October 20, 2010
Recall Status1 Terminated 3 on July 09, 2012
Recall Number Z-0095-2011
Recall Event ID 56279
510(K)Number K880402  
Product Classification Neurosurgical Paddie - Product Code HBA
Product Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card)
Product code: 24-5403
Code Information 09A0061 09B0310 09C0708  09C0709  09C0709  09E1139  09F1516 09F1517  09G1830  09G1830  09H2170  09J2622  09H2170  09J2622  09L3080 10B0196 10B0317  10C0442  10B0318  10C0442 Lot numbers:  8L2688  
Recalling Firm/
Manufacturer		 Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham MA 02767
For Additional Information Contact Same
508-828-3532
Manufacturer Reason
for Recall		 Surgical Pattie x-ray stripe (radio-opaque marker) may become detached
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 229 boxes (100 cards/10 patties each card)
Distribution Nationwide Foreign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore,
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HBA and Original Applicant = Codman & Shurtleff, Inc.
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