Device product
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.
Z-1522-2018
Product summary
- Event
- Event 79692
- Status
- Terminated
- Classification
- Class II
- 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)
- Official record key
device-enforcement:Z-1522-2018
Official wording
Reason: There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.
Code information: Lot Number 360610, 333020
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.
Derived failure modes
-
Unknown
There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.