Orthosensor recalls VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left models with fluid in posterior lateral corner post-surgery. Affected units have specific lot numbers and UDI.
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Orthosensor is recalling certain VERASENSE models for Zimmer Biomet Persona CR E-F/3-11 Left implants due to reported fluid in the posterior lateral corner after surgery. This could affect surgical outcomes and requires immediate attention.
The hazard involves fluid accumulation in the posterior lateral corner area after surgery, which may impact the implant's function and surgical results. This issue was reported by users but does not specify how it causes harm or the severity.
Patients who received the specific VERASENSE implant models with lot numbers 20568, 20575, 20581, 20584, 20621, 20623, or 20628 are affected. Those with the UDI 00816818021430 are at higher risk.
Check if your implant has lot numbers 20568, 20575, 20581, 20584, 20621, 20623, or 20628. The unique device identifier (UDI) 00816818021430 also identifies affected units.
Review your implant's lot numbers and unique device identifier (UDI) to confirm if it matches the affected models listed.
Orthosensor reports fluid in the posterior lateral corner post-surgery for some VERASENSE implants, but does not specify the exact risk or harm.
The recall does not provide a remedy, so contact Orthosensor directly for guidance.
Check your implant's lot numbers (20568, 20575, 20581, 20584, 20621, 20623, 20628) or UDI 00816818021430.
We’ve drafted a message you can send Orthosensor to request your refund or repair — edit it as you like.
Subject: Recall Z-0082-2019 — Orthosensor Orthosensor Hello, I own a Orthosensor that is covered by recall Z-0082-2019 from Orthosensor. 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.
