Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1461-2008

Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number...

Alcon Laboratories / initiated 2008-03-07 / Terminated / root cause: design

Alcon Research, Ltd began a recall of Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable; Alcon Laboratories... on . The reason FDA records is "Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1461-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Alcon Laboratories
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.
Product code
HNR Forceps, Ophthalmic
Reason for recall
Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.
Root cause tag
design
FDA root cause
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.
Product codes and lots
Lot Numbers: F58834, F60464, F60465 and F60466.