RecallRadar

FDA Device recall Z-0721-2018

Zimmer Segmental System, ZSS Distal Femur

On 2018-03-07 the FDA classified a Class II recall of Zimmer Segmental System, ZSS Distal Femur by Zimmer Biomet, citing the products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0721-2018
ClassificationClass II
Statusterminated
Initiated2017-08-01
Published2018-03-07
Last updated2026-09-13 11:54 UTC
CompanyZimmer Biomet
DistributionUS

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.

Identifiers

code_info
a. Item No. 00585001201 (Lot Expiration Date Before 07/31/2026); b. Item No. 00585001202 (Lot Expiration Date Before…a. Item No. 00585001201 (Lot Expiration Date Before 07/31/2026); b. Item No. 00585001202 (Lot Expiration Date Before 07/31/2026); c. Item No. 00585001301 (Lot Expiration Date Before 08/31/2026); d. Item No. 00585001302 (Lot Expiration Date Before 07/31/2026)

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0721-2018%22

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