Device product
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
Z-1169-2020
Product summary
- Event
- Event 84714
- Status
- Terminated
- Classification
- Class II
- Quantity
- 140 total units
- Official record key
device-enforcement:Z-1169-2020
Official wording
Reason: The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
Code information: Lot SO2040929 ***Updated 7/9/20*** Lot SO2040602 Lot SO2037408 (None of this lot distributed in the US / OUS distribution only)
Distribution pattern: Domestic distribution to IA, MA, NY, OH, and PA. Foreign distribution to Canada, China, Hungary, United Kingdom, and Singapore. ***Updated 7/9/20*** Expanded notice includes 6 new countries: Belgium, France, Germany, Maldives, New Zealand, and UAE
Derived failure modes
-
Unknown
The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.