Devices

Device Recall Ascent POCTS (Posterior Occipital Cervical Thoracic System)

Model / Serial
Part Numbers: 65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330; Lot numbers: 009, 010, 011, 018, 019, 031, 048, 064, 084 and 107.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide: USA and countries of China, Cyprus, Turkey and Switzerland.
Product Description
Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330), Multi-Axial Screw, 4.0mm x 26mm;Implant grade Titanium Alloy; Blacksone Medical Inc., 90 Brookdale Drive, Springfield, MA 01104.
Manufacturer
Blackstone Medical, Inc.
1 Event
- Recall of Device Recall Ascent POCTS (Posterior Occipital Cervical Thoracic System)

Manufacturer

Blackstone Medical, Inc.

Manufacturer Address
Blackstone Medical, Inc., 1211 Hamburg Tpke, Suite 300, Wayne NJ 07470
Manufacturer Parent Company (2017)
Orthofix Medical, 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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