Burr, Orthopedic
FDA adverse event reports and recall history for burr, orthopedic (product code HTT), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 414
- Deaths
- 0
- Injuries
- 63
- Malfunctions
- 313
Reports per year
Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2017-05-15TerminatedNonconforming Material/Component
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation
the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
- 2014-05-09TerminatedLabeling mix-ups
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.
- 2013-02-04TerminatedNonconforming Material/Component
Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
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.
- 2011-10-21TerminatedEmployee error
"***REF QD11-6B***6 mm Fluted Ball. Use with QD11 Attachments. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***" Lot number: 319149. Product Usage: Cutting and shaping bone including bones of the spine and cranium.
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.
- 2011-10-21TerminatedEmployee error
"***REF QD8-5B***5 mm Fluted Ball. Use with QD8 Attachments. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***" Lot numbers: B133005588. Product Usage: Cutting and shaping bone including bones of the spine and cranium.
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.
- 2011-10-21TerminatedEmployee error
"***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. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***" Lot number: B123005596. Product Usage: Cutting and shaping bone including bones of the spine and cranium.
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.
- 2011-10-21TerminatedEmployee error
"***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. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***" Lot number: B073004223. Product Usage: Cutting and shaping bone including bones of the spine and cranium.
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.
- 2011-10-21TerminatedEmployee error
"***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 ***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***" Lot number: 319461, B093004589. Product Usage: Cutting and shaping bone including bones of the spine and cranium.
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.
- 2011-10-21TerminatedEmployee error
"***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***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***" Lot number: B053003318. Product Usage: Cutting and shaping bone including bones of the spine and cranium.
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.
- 2011-10-21TerminatedEmployee error
"***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. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***" Lot number: B143004666. Product Usage: Cutting and shaping bone including bones of the spine and cranium.
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.
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