Zimmer Biomet recalls Ultra-Drive Irrigation Tubing Assembly (lot numbers listed) due to insufficient shelf life data supporting 10-year label. Consumers should check if their product has listed lot numbers and contact for details.
The products do not have sufficient data to support the labeled shelf life of 10 years.
Zimmer Biomet is recalling Ultra-Drive Irrigation Tubing Assembly (Reference Number 423834) because the product lacks sufficient data to support its 10-year shelf life claim. This means the tubing may degrade faster than labeled, potentially affecting surgical safety.
The tubing assembly does not have enough data to confirm it remains safe and effective for 10 years as labeled. This could mean the product degrades faster than intended, potentially affecting surgical outcomes if used beyond its safe period.
Orthopedic surgeons and medical professionals who use the Ultra-Drive System for bone and cement procedures are most likely affected. The risk is low as the issue relates to shelf life data, not immediate safety hazards.
Check if your tubing has the reference number 423834 and one of the listed 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.
Compare your tubing's lot number to the list provided in the recall notice to determine if it is affected.
The products do not have sufficient data to support the labeled shelf life of 10 years.
Check if your tubing has the reference number 423834 and one of the listed lot numbers. Contact Zimmer Biomet for further instructions.
The recall is due to shelf life data issues, not an immediate safety hazard. The risk is low as the product may degrade faster than labeled but does not pose a direct injury risk in normal use.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1963-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1963-2019 from Zimmer Biomet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
