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AESCULAP

Aesculap AG · Model FD113D · UDI-DI 04046963336721

GES Prescription

510(k) clearances

970

Adverse events

Recalls

304

Facilities

Description

Diamond Knife, 8" (205 mm), round, sharp, round handle, gold (7 facets)

Recalls

Date	Firm	Reason
2022-10-27	Southmedic, Inc.	Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold
2016-06-27	Aspen Surgical Puerto Rico Corp.	After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil
2012-08-15	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.	Potential for bent tips.
2012-08-15	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.	Potential for bent tips.
2012-08-15	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.	Potential for bent tips.
2012-08-15	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.	Potential for bent tips.
2009-09-29	Merit Medical Systems, Inc.	Potential sterility breach caused by excessive shipment damage.
2008-11-17	Miltex, Inc.	Blade may break: Over milling of the blade resulted in tip more narrow than specified.
2007-08-10	Becton Dickinson & Company	Complaints received of rust on the blades of BD Bard-Parker Surgical blades.
2007-08-10	Becton Dickinson & Company	Complaints received of rust on the blades of BD Bard-Parker Surgical blades.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.