Linkbio recalls medium/small LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP (item 15-2220/46) due to potential early loosening from improper implant placement. Affected patients should consult their surgeon.
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
Linkbio is recalling medium and small size LINK SLED Knee System implants because they may loosen too soon after surgery if not positioned correctly during implantation. This could lead to earlier revision surgery than expected.
The implant may loosen earlier than expected if not positioned correctly during surgery or if cementing technique is inadequate. This can cause the implant to fail prematurely, requiring revision surgery.
Patients who received the medium or small size LINK SLED Knee System implants (item 15-2220/46) from Linkbio. Those with improper surgical technique or inadequate cementing are at higher risk.
Check if your implant has the model name 'LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP' and item number 15-2220/46. The product was sold with all lot numbers within expiration date.
Contact your surgeon to determine if your implant is affected by the recall and whether revision surgery might be needed.
The recall does not require immediate discontinuation. Patients should consult their surgeon to assess if revision surgery is needed.
The item number is 15-2220/46.
No, this recall specifically affects medium and small size LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP implants (item 15-2220/46).
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1540-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1540-2023 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.
