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Burr, Orthopedic
FDA product code HTT · Class 1 · Orthopedic
1,481
Registered devices
414
Adverse events
23
Recalls
4
510(k) clearances
Devices with this code
AccuBlade — Hangzhou Rejoin Mastin Medical Device Co., Ltd.MicroAire — ProvisionDIAMOND CARPAL — Stryker GmbHBrasseler USA — ProvisionStryker — ProvisionConmed/Linvatec — ProvisionIMEDICOM HIGH SPEED BLADE — IMEDICOM CO., LTD.IMEDICOM HIGH SPEED BLADE — IMEDICOM CO., LTD.Brasseler USA — ProvisiongSource — GSOURCE LLCStryker — ProvisionMicroAire — ProvisiongSource — GSOURCE LLCBrasseler USA — ProvisionIntegra® PyroSphere® — Ascension Orthopedics, Inc.Brasseler USA — ProvisionMicroAire — ProvisionConmed/Linvatec — ProvisionStryker — ProvisionSHANNON SHORT BURR — BRM EXTREMITIES SRLIMEDICOM HIGH SPEED BLADE — IMEDICOM CO., LTD.BURR — KLS-Martin L.P.IMEDICOM HIGH SPEED BLADE — IMEDICOM CO., LTD.IMEDICOM HIGH SPEED BLADE — IMEDICOM CO., LTD.
Recent 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 si |
| 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 degrade |
| 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 degrade |
| 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 degrade |
| 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 degrade |
| 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 degrade |
| 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 degrade |
| 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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