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Recall Observatory FDA recall evidence

Device product

Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.

Z-1962-2019

June 04, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83085
Status
Terminated
Classification
Class II
Quantity
8478 total
Official record key
device-enforcement:Z-1962-2019

Official wording

Reason: The products do not have sufficient data to support the labeled shelf life of 10 years.

Code information: Lot Numbers: 221437 211324 211638 212670 212877 213350 213612 214315 214545 214994 216550 216610 217760 217766 218921 219825

Distribution pattern: Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The products do not have sufficient data to support the labeled shelf life of 10 years.