FDA Device

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.

Hazard

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

What You Should Do

Remedy

Urgent Medical Device Recall notification letters dated 6/4/19 were sent to customers.

Products

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 ceme
Brand
Zimmer Biomet, Inc.
UPC
Lot Numbers: 221437 211324 211638 212670 212877 213350 213612 214315 214545 214994 216550 216610 217760 217766 218921 219825

Units Affected

8478 total