FDA-Device2020-02-19Class II
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
DePuy Orthopaedics, Inc.
Hazard
The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
Sold states
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
Affected count
140 total units
Manufactured in
700 Orthopaedic Dr, Warsaw, IN, United States
Products
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1169-2020Don't want to check this manually?
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