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Omega Surgical Instruments Inc · Model MR9BA60 · UDI-DI 00817438028014

GFF Prescription

510(k) clearances

2,110

Adverse events

Recalls

179

Facilities

Description

6.0 MM ROUND CUTTING HIGH SPEED SS BUR, 9 CM, BLUE

Recalls

Date	Firm	Reason
2021-02-09	In2Bones, SAS	This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the brea
2019-10-18	Brasseler USA I Lp	One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
2019-01-14	Arthrex, Inc.	Devices may generate excessive heat during use.
2016-11-08	Wright Medical Technology, Inc.	The firm discovered a lack of adequate documentation confirming sterility on certain products.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2015-12-21	ConMed Corporation	Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly. During the manufacturing process an assembly error occurr
2015-02-11	EXP Pharmaceutical Services Corp	EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re
2013-05-03	Surgical Instrument Service And Savings, Inc.	The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
2012-06-11	The Anspach Effort, Inc.	Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).
2011-03-31	The Anspach Effort, Inc.	Cutter was longer than was stated on the label

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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.