Recall Z-2084-2014— DePuy Orthopaedics, Inc.

Name: FDA recall Z-2084-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-03

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2014-06-03, terminated 2017-05-17. It names one FDA 510(k) clearance: K102080. Product: RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.. Reason: The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-03
Terminated: 2017-05-17
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K102080 — DEPUY RECLAIM REVISION HIP SYSTEMDepuy(Ireland)·cleared 2010-11-23

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

RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

Reason for recall

The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.

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