Skip to content
Recall Observatory FDA recall evidence

Device product

The 2nd Assist Knee Positioner

Z-0803-2018

September 07, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 79141
Status
Terminated
Classification
Class II
Quantity
38,879 units
Official record key
device-enforcement:Z-0803-2018

Official wording

Reason: Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.

Code information: Item# 740026

Distribution pattern: Nationally

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile packaging barrier to be breached