Recalls / —
—#173476
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.
- FDA product code
- JDX — Instrument, Surgical, Sonic And Accessory/Attachment
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K031280
- Affected lot / code info
- Lot Numbers: 221437 211324 211638 212670 212877 213350 213612 214315 214545 214994 216550 216610 217760 217766 218921 219825
Why it was recalled
The products do not have sufficient data to support the labeled shelf life of 10 years.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Urgent Medical Device Recall notification letters dated 6/4/19 were sent to customers.
Recalling firm
- Firm
- Zimmer Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan.
Timeline
- Recall initiated
- 2019-06-04
- Terminated
- 2021-07-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #173476. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.