PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 7, 2018 Initiated: August 1, 2017 #Z-0721-2018

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.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
3,350 units total
Distribution
Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, Australia, Bahamas, Brazil, Canada, China, Dominican Republic, England, France, Germany, Israel, Japan, South Korea, Lebanon, Malaysia, Mexico, Netherlands, Panama, Singapore, Spain, Switzerland, and Thailand.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Zimmer Biomet, Inc.. Units affected: 3,350 units total.
Why was this product recalled?
The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 7, 2018. Severity: Moderate. Recall number: Z-0721-2018.