Devices

Device Recall Xia 3 AntiTorque Key

Model / Serial
Lot Codes (510k exempt): 07F116, 07F117, 085525, 086577, 086578, 087232, 087233, 088604.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Nationwide Distribution
Product Description
Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026. || Product Usage: : || Reusable instrument used to aid in the final tightening of the spinal construct. Intended Use: The Anti-Torque Key allows the Torque Wrench to align with the tightening axis and maximizing the torque needed to lock the implant assembly during final tightening of the spinal construct.
Manufacturer
Stryker Spine
1 Event
- Recall of Device Recall Xia 3 AntiTorque Key

Manufacturer

Stryker Spine

Manufacturer Address
Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
Manufacturer Parent Company (2017)
Stryker
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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