Z-0705-03

Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm

Name: Z-0705-03 Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm
Creator: Surgical Specialties Corp
Published: 2003-01-07
License: https://open.fda.gov/license/

Surgical Specialties Corp / initiated 2003-01-07 / Terminated / root cause: labeling and UDI

FDA source

Surgical Specialties Corp began a recall of Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm on 2003-01-07. The reason FDA records is "size mislabeled on product handle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0705-03
Status: Terminated
Initiated: 2003-01-07
Posted: 2003-04-01
Terminated: 2003-03-31
Recalling firm: Surgical Specialties Corp
Product: Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm.
Product code: HNN Knife, Ophthalmic
Reason for recall: size mislabeled on product handle
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On 1/7/03, one account was contacted via telephone. On 1/10/03, a recall letter was faxed to that account. On 3/11/03, this wholesale account was asked to contact a hospital sub account that received a direct shipment. The other account was the complainant and telephone communications were occurring.
Quantity in commerce: 635 units
Distribution: The product was shipped to 2 wholesale accounts in PA and LA.
Product codes and lots: Model # 75-2525, Lot #M118200

Product code HNN

K822112Class IOphthalmic KnifeSharpoint, Inc. / cleared 1982-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)