Orthosensor, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1029-2015)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2015.
Data Source: FDA.
Product Description:
Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Product Classification:
Class II
Date Initiated: December 5, 2014
Date Posted: February 4, 2015
Recall Number: Z-1029-2015
Event ID: 69963
Reason for Recall:
Presence of one inoperable (dead) sensor pad.
Status: Terminated
Product Quantity: 22 devices
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.
Distribution Pattern:
US Distribution to the states of : IL, MI, NY, CA, VA and NV.
Voluntary or Mandated:
Voluntary: Firm initiated