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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 November 30, 2010
Date Posted April 20, 2011
Recall Status1 Terminated 3 on March 14, 2013
Recall Number Z-2032-2011
Recall Event ID 57340
Product Classification device, monitoring, intracranial pressure - Product Code GWM
Product Codman Cranial Hand Drill
Product Code: 82-6607
This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
Code Information Lot Codes:  429084 429085 429086 430880 430881 430882 430883 430884 430885 430886 434297 434298 434299 JA272  JA296  JA238  KA230 KA265  LA212 LA247  LA279 MA215  MA254 MA299 AB207  AB288 AB289 BB312 CB250 DB203 DB204  DB207 EB328 EB329  EB343  EB344  FB232 422690 422691  422692  422693  422694  422695  422696  422697 422698 422699 422700 425478 424537 429080 429081 429082 429083 FB238 FB345 GB204 GB205 GB206 GB287 HB201 HB202 HB280 JB200 JB288 KB210 KB276 KB277 LB253 LB303 LB304 MB255   
Recalling Firm/
Manufacturer		 Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham MA 02767
For Additional Information Contact SAME
508-828-3532
Manufacturer Reason
for Recall		 Packaging defect may compromise sterility of device
FDA Determined
Cause 2		 Package design/selection
Action The firm, Codman, sent an "Important Notice Urgent- Voluntary Product Recall Notification" letter dated November 30, 2010 to its customers via FedX. On January 7, 2011, Codman expanded the recall to four additional product codes.On January 31, 2011, the firm issued a supplemental recall letter and identified one additional product code: 80-11197. The letters described the product, problem and actions to be taken. The customers were instructed to identify the unused affected products in their inventory and follow the recall instructions provided: 1) If you have NO product to return, please advise Codman as soon as possible using the FACSIMILE form attached and fax to 508-828-6118 and 2) if you DO have product to return, please call 1-800-225-0460, Option 4, for instructions for return. Codman is presently working toward supplying replacement products as soon as possible. Please call Customer Service to check on the status of product availability at 1-800-225-0460. Should you have any questions regarding this recall, please call Customer Service at 1-800-225-0460 or your local Codman Representative.
Quantity in Commerce 9038 units
Distribution Worldwide distribution: USA including states of :AL, FL,GA, KY, MA, MI, MN, MS, OR, PA, RI, UT,WI and WV; and countries including: Argentina, Australia, Canada, Bahamas , Belgium, Dubai, Japan, Madrid, Mexico, New Zealand, Saudia Arabia, UAE, Uruguay, and United Kingdom.
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.
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