Z-1029-2015 Class II Terminated
FDA device recall Z-1029-2015 was initiated by Orthosensor, Inc. on December 5, 2014 and is designated Class II. Reason for recall: Presence of one inoperable (dead) sensor pad. The recall status is terminated (terminated March 13, 2015). Affected quantity: 22 devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 4, 2015
- Initiation Date
- December 5, 2014
- Termination Date
- March 13, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 devices
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.
Distribution Pattern
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.