Zimmer Biomet recalls Ultra-Drive Hose/Drape Assembly (lot numbers listed) due to insufficient shelf life data for 10-year label. Consumers should check if their product matches the listed lots.
The products do not have sufficient data to support the labeled shelf life of 10 years.
Zimmer Biomet is recalling Ultra-Drive Hose/Drape Assembly products with specific lot numbers because the products lack sufficient data to support their 10-year shelf life claim. This means the products might not be safe for use beyond the intended time frame.
The products do not have enough data to confirm they remain safe and effective for 10 years as labeled. This could lead to potential issues with the product's performance over time, but the hazard is not immediately dangerous.
Orthopedic surgeons and medical staff who use the Ultra-Drive System for bone and cement procedures may own these products. Those with the listed lot numbers are most at risk.
Check the lot number on your Ultra-Drive Hose/Drape Assembly. The affected lots are: 221437, 211324, 211638, 212670, 212877, 213350, 213612, 214315, 214545, 214994, 216550, 216610, 217760, 217766, 218921, 219825.
Identify the lot number on your Ultra-Drive Hose/Drape Assembly to see if it matches the listed affected lots.
The products do not have sufficient data to support the labeled shelf life of 10 years.
Check the lot number on your product to see if it matches the listed affected lots. If it does, contact Zimmer Biomet for further instructions.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1962-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1962-2019 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.