Bur, Surgical, General & Plastic Surgery

Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Pol

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 occurred which caused inadvertent mixing of two sizes of bearings.

Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A;

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 registered and had their own quality systems.

Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only

Cutter was longer than was stated on the label

Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome.

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).

- Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Burrs

SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable

ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773

Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal.

Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070

The curve in the shaft of the bur was only 15 degrees not the labeled 40 degrees.

Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514

The firm discovered a lack of adequate documentation confirming sterility on certain products.

BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill

One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.