Recall Z-1169-2020— DePuy Orthopaedics, Inc.

Name: FDA recall Z-1169-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-03

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2020-01-03, terminated 2021-08-12. It names one FDA 510(k) clearance: K043223. Product: SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.. Reason: The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-01-03
Terminated: 2021-08-12
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K043223 — DEPUY CAS KNEE INSTRUMENTATIONDePuy Orthopaedics, Inc.·cleared 2005-03-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.