Recall Z-0721-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0721-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-01

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-08-01, terminated 2020-03-18. It names one FDA 510(k) clearance: K070978. Product: Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.. Reason: The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-01
Terminated: 2020-03-18
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K070978 — ZIMMER SEGMENTAL SYSTEMZimmer, Inc.·cleared 2007-07-03

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

Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.

Reason for recall

The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.

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