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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0176-2021 - Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.
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2
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10/21/2020
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FEI # 3003800209 Bien-Air Surgery Sa
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Z-0177-2021 - Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blade...
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2
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10/21/2020
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FEI # 3003800209 Bien-Air Surgery Sa
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Z-0180-2021 - Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues a...
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2
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10/21/2020
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FEI # 3003800209 Bien-Air Surgery Sa
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Z-0179-2021 - Stryker Instruments REF 5452-007-000 SN *******
S2 MINI FOOT Pedal - Product Usage:
The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such a...
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2
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10/21/2020
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FEI # 3003800209 Bien-Air Surgery Sa
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Z-0178-2021 - Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat...
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2
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10/21/2020
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FEI # 3003800209 Bien-Air Surgery Sa
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