Medical device recalls Moderate risk

DePuy Orthopaedics, Inc. recalls SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.

Recall date
January 3, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1169-2020
FDA classification
Class II
Brand / firm
DePuy Orthopaedics, Inc.
Sold / distributed
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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

Get recall alerts

Free email alert whenever DePuy Orthopaedics, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: DePuy Orthopaedics, Inc.