Medacta recalls GMK knee implants with a small risk of screw back-out after surgery. Affected models include specific part numbers and serial numbers for cemented total knee replacements.
Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.
Medacta is recalling GMK knee implants designed for cemented use in total knee replacements due to a small risk of screw back-out after surgery. This could potentially lead to complications if not properly addressed during implantation.
The recall addresses a small post-operative risk where screws in the knee implant may back out after surgery. This can happen during the implantation process if the correct torque is not applied, potentially causing complications.
Patients who received the GMK knee system implants with specific part numbers and serial numbers for cemented total knee replacements. Surgeons and medical staff involved in the implant procedure are most at risk.
Check for GMK knee implants with part numbers ranging from 02.12.0110FL to 02.12.0620FL, or 02.12.0110FR to 02.12.0620FR, or 02.07.0110PSF to 02.07.0620PSF. All serial numbers on these implants are affected.
Review the part numbers and serial numbers on your GMK knee implant to confirm if it falls within the affected ranges.
Medacta has observed a small post-operative rate of screw back-out (0.1%) in the GMK knee system, so they recommend using a torque limiting driver during implantation.
Check the part numbers and serial numbers on your implant to see if it's affected. If it is, contact Medacta for further instructions.
The recall does not provide a specific fix; it emphasizes using the correct torque limiting driver during implantation to reduce the risk.
We’ve drafted a message you can send Medacta to request your refund or repair — edit it as you like.
Subject: Recall Z-0266-2018 — Medacta Medacta Hello, I own a Medacta that is covered by recall Z-0266-2018 from Medacta. 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.
