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.
Reported: July 24, 2019 Initiated: June 4, 2019 #Z-1962-2019
Product Description
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.
Reason for Recall
The products do not have sufficient data to support the labeled shelf life of 10 years.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 8478 total
- Distribution
- Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zimmer Biomet, Inc.. Units affected: 8478 total.
Why was this product recalled? ▼
The products do not have sufficient data to support the labeled shelf life of 10 years.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2019. Severity: Moderate. Recall number: Z-1962-2019.
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