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Ambler Surgical

AMBLER SURGICAL CORP. · Model Hofmann T-incision marker · UDI-DI 00190660217709

HMR Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Hofmann T-incision marker, 3 7/8'', two parallel 5.0mm marking blades spaced 6.0mm apart, flat handle

Recalls

Date	Firm	Reason
2010-12-23	Aspen Surgical Products, Inc.	Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
2010-12-23	Aspen Surgical Products, Inc.	Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
2010-12-23	Aspen Surgical Products, Inc.	Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
2010-12-23	Aspen Surgical Products, Inc.	Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
2010-12-23	Aspen Surgical Products, Inc.	Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
2010-12-23	Aspen Surgical Products, Inc.	Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.

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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.