PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: February 19, 2020 Initiated: January 3, 2020 #Z-1169-2020

Product Description

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

Reason for Recall

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

Details

Recalling Firm
DePuy Orthopaedics, Inc.
Units Affected
140 total units
Distribution
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
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 140 total units.
Why was this product recalled?
The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 19, 2020. Severity: Moderate. Recall number: Z-1169-2020.