Recall Z-2949-2018— DePuy Orthopaedics, Inc.

Name: FDA recall Z-2949-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-18

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2018-07-18, terminated 2019-04-17. It names one FDA 510(k) clearance: K952830. Product: P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830. Reason: This unit may be missing the screw/collet Assembly.

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-07-18
Terminated: 2019-04-17
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K952830 — DARWIN KNEE SYSTEM (TC3)Johnson & Johnson Professionals, Inc.·cleared 1996-01-18

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

P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830

Reason for recall

This unit may be missing the screw/collet Assembly

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