FDA recall Z-1169-2020

Product

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.

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

Key facts

Status

Terminated

Initiation date

2020-01-03

Report date

2020-02-19

Termination date

2021-08-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1169-2020