Recall Z-1522-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1522-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-03

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-04-03, terminated 2018-07-02. It names one FDA 510(k) clearance: K042409. Product: Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.. Reason: There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-04-03
Terminated: 2018-07-02
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K042409 — MODULAR ARTHRODESIS NAILBiomet, Inc.·cleared 2004-12-02

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

Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.

Reason for recall

There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.

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