Skip to content
Recall Observatory FDA recall evidence

Device product

SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.

Z-1169-2020

January 03, 2020

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
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

    reason.no_named_rule · v1.0.0

    The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.