Reported Jul 24, 2019 · Terminated
Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- Ultra-Drive Irrigation Tubing Assembly
- Reference Number 423834 - Product UsageItem used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications
- Lot codes and dates
- Lot Numbers
211325209586210002210488210566210848210867210972211172211237212076212488212622212928212966214005214051214118214255214499214546214669214822214995215048215329215445215524215623216489216611217370217556217761217767218667219305219661219913220935
- Lot Numbers
- Amount recalled
- 8478 total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
The products do not have sufficient data to support the labeled shelf life of 10 years.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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