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Sklar®

SKLAR CORPORATION · Model 06-2862 · UDI-DI 10649111148552

FTY

510(k) clearances

435

Adverse events

Recalls

398

Facilities

Description

STEEL RULER 8"

Recalls

Date	Firm	Reason
2015-03-05	SpineFrontier, Inc.	The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use
2010-10-22	Lemaitre Vascular, Inc.	Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22	Lemaitre Vascular, Inc.	Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22	Lemaitre Vascular, Inc.	Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22	Lemaitre Vascular, Inc.	Box label (Top Part). Lot and Expiration Date information were switched.

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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.