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.
FDA Recall Z-0026-04 · Posted 2003-10-15
Advertisement
Recalling FirmSurgical Specialties Corp
Recall StatusTerminated
Product CodeHNN
Date Initiated2003-08-21
Date Terminated2004-01-13
Product Quantity666 units
Reason for Recall
text on product handle is incorrect
Firm Action
The consignees were notified via fax on 8/21/03. One customer received a recall letter via mail on 8/22/03.
Root Cause
Other
Distribution Pattern
The products were shipped to two hospitals in CA, two sales representatives in NC & IL, and three wholesalers in IL, Belgium, Canada, and Austrailia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement