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Terminated

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

FDA Recall Z-0705-03 · Posted 2003-04-01

Recalling FirmSurgical Specialties Corp
Recall StatusTerminated
Product CodeHNN
Date Initiated2003-01-07
Date Terminated2003-03-31
Product Quantity635 units

Reason for Recall

size mislabeled on product handle

Firm 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.

Root Cause

Other

Distribution Pattern

The product was shipped to 2 wholesale accounts in PA and LA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K822112OPHTHALMIC KNIFESharpoint, Inc. · 1982-08-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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