Recall Z-1461-2008 ยท HNR Forceps, Ophthalmic
Alcon Research, Ltd
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.
| Date | May 14, 2008 (initiated Mar 7, 2008) |
| Status | Terminated |
| Reason | Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction. |
| 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 | 24 units |
| Distribution | Nationwide Distribution including states of AL and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.