Z-1963-2019Class II

Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 -

Name: Z-1963-2019 Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 -
Creator: Zimmer Biomet, Inc.
Published: 2019-06-04
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-06-04 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the... on 2019-06-04. FDA classified it as Class II and gives the reason as "The products do not have sufficient data to support the labeled shelf life of 10 years". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1963-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-04
Posted: 2019-07-12
Terminated: 2021-07-21
Recalling firm: Zimmer GmbH
Product: 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.
Product code: JDX Instrument, Surgical, Sonic And Accessory/Attachment
Reason for recall: The products do not have sufficient data to support the labeled shelf life of 10 years.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall notification letters dated 6/4/19 were sent to customers.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1963-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1962-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12
Z-1963-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12

Product code JDX

K031280Class IIUltra-Drive 3Biomet, Inc. / cleared 2003-09-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)