CLASS II Device recall · Reported 24 Jul 2019 · FDA Enforcement Report

Ultra-Drive Irrigation Tubing Assembly, Reference Number recalled

Zimmer Biomet is recalling Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834, distributed nationwide in the US. The recall was initiated on 4 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 211325 209586 210002 210488 210566 210848 210867 210972 211172 211237 212076 212488 212622 212928 212966 214005 214051 214118 214255 214499 214546 214669 214822 214995 215048 215329 215445 215524 215623 216489 216611 217370 217556 217761 217767 218667 219305 219661 219913 220935

Quantity recalled8478 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1963-2019
FDA event ID: 83085
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 4 Jun 2019
FDA classified: 12 Jul 2019
Reported: 24 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

4 Jun 2019	Recall initiated by company
12 Jul 2019	Classified by FDA	+38 days
24 Jul 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - 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.

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot Numbers: 211325 209586 210002 210488 210566 210848 210867 210972 211172 211237 212076 212488 212622 212928 212966 214005 214051 214118 214255 214499 214546 214669 214822 214995 215048 215329 215445 215524 215623 216489 216611 217370 217556 217761 217767 218667 219305 219661 219913 220935

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 83085

Reported	Class	Recall	Company	Reason	Where
24 Jul 2019	CLASS II	Ultra-Drive Hose/Drape Assembly, Reference Number recalled	Zimmer Biomet	Other	Nationwide

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