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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
