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
Recall
- Recall Number
- Z-2032-2011
- Event Number
- 57340
- Firm
- Codman & Shurtleff, Inc.
- FEI Number
- 3002947440
- Product Code
- GWM
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- November 30, 2010
- Posted
- April 20, 2011
- Terminated
- March 14, 2013
- Address
- 325 Paramount Drive, Raynham, MA, 02767
Description
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
Packaging defect may compromise sterility of device
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.
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.
9038 units