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U.S. Department of Health and Human Services

Class 3 Device Recall Alcon/Grieshaber Morris ILM Forceps, Direct Action

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  Class 3 Device Recall Alcon/Grieshaber Morris ILM Forceps, Direct Action see related information
Date Initiated by Firm March 07, 2008
Date Posted May 14, 2008
Recall Status1 Terminated 3 on July 18, 2008
Recall Number Z-1461-2008
Recall Event ID 47401
Product Classification Manual ophthalmic surgical instrument - Product Code HNR
Product Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable; Alcon Laboratories, Inc., Fort Worth, TX 76134.
Code Information Lot Numbers: F58834, F60464, F60465 and F60466.
Recalling Firm/
Manufacturer		 Alcon Research, Ltd
6201 South Fwy
Fort Worth TX 76134-2001
For Additional Information Contact
817-551-6813
Manufacturer Reason
for Recall		 Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.
FDA Determined
Cause 2		 Device Design
Action Consignees were notified by an Urgent Medical Device Recall that was sent via fax on 03/07/08. Users were instructed to cease using the affected products and to return a Recall Acknowledgement Form to the recalling firm. The sales representative will pick up the affected product and discuss replacement alternatives. For additional information, contact 1-800-757-9780.
Quantity in Commerce 24 units
Distribution Nationwide Distribution including states of AL and CA.
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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