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Terminated

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 Recall Z-1962-2019 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeJDX
Date Initiated2019-06-04
Date Terminated2021-07-21
Product Quantity8478 total

Reason for Recall

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

Firm Action

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

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031280ULTRA-DRIVE 3Biomet, Inc. · 2003-09-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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