Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0026-04

Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold...

Surgical Specialties Corp / initiated 2003-08-21 / Terminated

Surgical Specialties Corp began a recall of Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives on . The reason FDA records is "text on product handle is incorrect". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0026-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Surgical Specialties Corp
Product
Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Product code
HNN Knife, Ophthalmic
Reason for recall
text on product handle is incorrect
FDA root cause
Other
Action
The consignees were notified via fax on 8/21/03. One customer received a recall letter via mail on 8/22/03.
Quantity in commerce
666 units
Distribution
The products were shipped to two hospitals in CA, two sales representatives in NC & IL, and three wholesalers in IL, Belgium, Canada, and Austrailia.
Product codes and lots
M190500 exp 11/2007 and M203840 exp 12/2007