Burr, Orthopedic

Normed General Instruments

the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.

ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium

Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.

Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and S

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 used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented.

"***REF QD11-6B***6 mm Fluted Ball. Use with QD11 Attachments. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: T

The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.

"***REF QD8-5B***5 mm Fluted Ball. Use with QD8 Attachments. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The

The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.

"***REF BLU-5***5 mm Fluted Ball. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer:

The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.

"***REF BLU-39***5 mm Fluted Acorn. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer:

The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.

"***REF BLU-LS9-5E***4.7 mm x 20 mm Fluted Drum, Side Cut Only. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Ma

The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.

"***REF GRE-1***1.85 mm x 16 mm Fluted Router. Use with B-GREEN Attachments.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Ma

The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.

"***REF LHD-6B-M***6 mm Fluted Ball. Use with LONG-HD Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer:

The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.