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
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.
