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.
FDA Recall Z-1461-2008 · Posted 2008-05-14
Advertisement
Recalling FirmAlcon Research, Ltd
Recall StatusTerminated
Product CodeHNR
Date Initiated2008-03-07
Date Terminated2008-07-18
Product Quantity24 units
Reason for Recall
Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution including states of AL and CA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement