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Terminated

2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled, Bevel, Up***One Unit STERILE R Disposable***Surgical Specialties Corporation***Reading, PA 19606***''

FDA Recall Z-0918-03 · Posted 2003-06-05

Recalling FirmSurgical Specialties Puerto Rico, Inc.
Recall StatusTerminated
Product CodeHNN
Date Initiated2003-05-07
Date Terminated2004-02-09
Product Quantity3,420 pieces

Reason for Recall

Incorrect handle was used in the manufacture of product 52-2761

Firm Action

On 5/7/03 the cusotmers were notified of the recall via fax.

Root Cause

Other

Distribution Pattern

Nationwide and worldwide. Distribution was to two accounts in the USA and four (4) foreign accounts.

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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