Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dyn...
FDA Recall #Z-1029-2015 — Class II — December 5, 2014
Product Description
Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Reason for Recall
Presence of one inoperable (dead) sensor pad.
Recalling Firm
Orthosensor, Inc. — Sunrise, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
22 devices
Distribution
US Distribution to the states of : IL, MI, NY, CA, VA and NV.
Code Information
Model SYK-TRCR 02, Lot # 091914V11770, Serial #s: 411654008, 411585023, 411654007, 411585032, 411585014, 411654016, 411585017, 411654015, 411585030, 411654020, 411654004, 411654010, 411585007, 411585005, 411654011, 411585036, 411585035, 411654018, 411654012, 411585011, 411654014, 411654005, 411654001, 411585003.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated