LINK Bio Corp recalls SymphoKnee Patella Sizing Template (Item 881-509/00) due to incorrect labeling from upside-down insertion during laser marking. Affected units have mixed markings on two arms.
The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.
LINK Bio Corp recalls their SymphoKnee Patella Sizing Template (Item 881-509/00) because the markings on two arms were mixed up due to improper insertion into the laser marking process. This labeling error could lead to incorrect sizing during knee surgery.
The template's markings were mixed up because it was inserted upside down during laser marking. This could cause incorrect patella sizing during surgery if the template is used without proper labeling.
Patients undergoing knee surgery who use this template for patella sizing are most at risk. The recall applies to specific units with the item number 881-509/00.
Check for the item number 881-509/00 on the template. Affected units were sold with the lot number C225066 and UDI-DI code 04026575310203.
Verify the item number on the template is 881-509/00.
The markings on two arms were mixed up because the template was inserted upside down during laser marking.
Check for the item number 881-509/00 and lot number C225066 on the template.
The recall does not specify a remedy, so contact LINK Bio Corp for guidance.
We’ve drafted a message you can send LINK BIO CORP to request your refund or repair — edit it as you like.
Subject: Recall Z-2445-2024 — LINK BIO CORP LINK BIO CORP Hello, I own a LINK BIO CORP that is covered by recall Z-2445-2024 from LINK BIO CORP. 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.