Linkbio recalls SymphoKnee System L-Shaped Femoral Augment (Sz 5-6 Tilastan) due to incorrect implant packaging. This could lead to wrong implant installation during knee replacement surgery.
Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
Linkbio is recalling a specific knee implant model because the packaging contains the wrong implant side. Using this incorrect implant could lead to improper knee surgery alignment.
The packaging contains the opposite implant side (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left). This mismatch could cause improper knee alignment during surgery if the wrong implant is used.
Patients who received this specific knee implant model during surgery are affected. Surgeons and hospitals using this implant model are most at risk.
Check for the product name 'SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan'. The item number is 880-325/13 and lot number 1910003.
Verify the implant side label matches Medial-Right/Lateral-Left as stated in the product description.
The packaging contains the incorrect implant side (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left), which could lead to improper knee alignment during surgery.
This is a manufacturing error in the packaging, not a direct safety hazard for the patient once implanted. The risk is during surgical installation.
Look for the product name 'SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan' with item number 880-325/13 and lot number 1910003.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1674-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1674-2023 from Linkbio. 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.