Recall Z-1461-2008
Alcon Research, Ltd · initiated March 7, 2008
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.
Codes / lots: Lot Numbers: F58834, F60464, F60465 and F60466.
Reason for recall
Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-1461-2008
- Initiated
- March 7, 2008
- Posted by FDA
- May 14, 2008
- Terminated
- July 18, 2008
- Product code
- HNR – Forceps, Ophthalmic
- Quantity
- 24 units
- Distribution
- Nationwide Distribution including states of AL and CA.
- Recalling firm
- Alcon Research, Ltd, Fort Worth, TX