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IMEDICOM HIGH SPEED BLADE

IMEDICOM CO., LTD. · Model NSR-514D · UDI-DI 08809288932209

HTT

510(k) clearances

414

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2017-05-11	Zimmer Gmbh	the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
2014-01-08	The Anspach Effort, Inc.	Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.
2012-09-05	The Anspach Effort, Inc.	Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials
2010-09-29	The Anspach Effort, Inc.	Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Sterile Bone Cutting Burs that was manufactured with incomplete flutes which could cause degraded cutting performanc
2010-09-29	The Anspach Effort, Inc.	Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Sterile Bone Cutting Burs that was manufactured with incomplete flutes which could cause degraded cutting performanc
2010-09-29	The Anspach Effort, Inc.	Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Sterile Bone Cutting Burs that was manufactured with incomplete flutes which could cause degraded cutting performanc
2010-09-29	The Anspach Effort, Inc.	Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Sterile Bone Cutting Burs that was manufactured with incomplete flutes which could cause degraded cutting performanc
2010-09-29	The Anspach Effort, Inc.	Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Sterile Bone Cutting Burs that was manufactured with incomplete flutes which could cause degraded cutting performanc
2010-09-29	The Anspach Effort, Inc.	Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Sterile Bone Cutting Burs that was manufactured with incomplete flutes which could cause degraded cutting performanc
2009-07-31	Linvatec Corp. dba ConMed Linvatec	ConMed Linvatec is recalling Ultrapower Bur, Diamond Wheel for possibility of a packaging breach in the sterile barrier.

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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.