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NOIR

Aesculap AG · Model FK968B · UDI-DI 04046963166380

LRY Prescription

510(k) clearances

756

Adverse events

Recalls

251

Facilities

Description

KERRISON NOIR Bone Punch conventional, 130 °, upwards cutting, 7 7/8", (200 mm), width: 1,500 mm, opening width: 9 mm, detachable, without ejector, thin, non-sterile, reusable, to be used with: JF120R

Recalls

Date	Firm	Reason
2017-10-23	Alto Development Corp	Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.
2016-01-08	DePuy Orthopaedics, Inc.	Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may r
2013-03-18	Clorox Healthcare Holdings, LLC (dba HealthLink)	Due to lack of sterilization.
2013-03-18	Clorox Healthcare Holdings, LLC (dba HealthLink)	Due to lack of sterilization.
2013-03-18	Clorox Healthcare Holdings, LLC (dba HealthLink)	Due to lack of sterilization.
2012-08-14	Biomet, Inc.	Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to p

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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.