Z-1522-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- April 3, 2018
- Termination Date
- July 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units (21 distribution events. The product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf)
Product Description
Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.
Reason for Recall
There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.
Distribution Pattern
The product was distributed to the following states: CT, FL, GA, IN, MA, MI, NY, and TX. The product was distributed to the following countries: Malaysia and Netherlands.
Code Information
Lot Number 360610, 333020