Devices

Device Recall Novel Spinal Spacer System

Model / Serial
Part Number(s): 64817-010 Lot Number(s): 623549; Part Number(s): 64817-012 Lot Number(s): 623551; Part Number(s): 64817-013 Lot Number(s): 623552; Part Number(s): 64817-014 Lot Number(s): 623553; Part Number(s): 64817-107 Lot Number(s): 623584; Part Number(s): 64113-012 Lot Number(s): 623619; Part Number(s): 64113-010 Lot Number(s): 623620; Part Number(s): 64765-109 Lot Number(s): 623909; and Part Number(s): 64733-124 Lot Number(s): 623778.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution -- CA, NV, FL, CT, TX, IA and WI.
Product Description
Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. || Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology.
Manufacturer
Alphatec Spine, Inc.
1 Event
- Recall of Device Recall Novel Spinal Spacer System

Manufacturer

Alphatec Spine, Inc.

Manufacturer Address
Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
Manufacturer Parent Company (2017)
Alphatec Holdings Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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