Atlas FDA

Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-s

FDA device recall Z-1461-2008 · posted 2008-05-14 · Terminated

Recall details

Recalling firm
Alcon Research, Ltd
Reason for recall
Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.
Action taken
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.
Root cause
Device Design
Status
Terminated
Product code
HNR
Quantity affected
24 units
Distribution
Nationwide Distribution including states of AL and CA.
Date initiated
2008-03-07
Date posted
2008-05-14
Date terminated
2008-07-18
Location
Fort Worth, TX

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