Waldemar Link recalls orthopedic prosthesis tibial components with model numbers Small (W 16-2817/02), Medium (W 16-2817/05), and Large (W 16-2817/07) due to risk of blind screws that cannot be loosened during surgery, potentially prolonging procedures.
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Waldemar Link is recalling orthopedic prosthesis tibial components with specific model numbers because blind screws may not loosen during surgery, leading to longer procedures. This recall affects patients who have received these implants and requires medical attention to prevent complications.
The blind screws in the modular tibial component may not be loosened during surgery, which can cause the surgical team to change procedures and prolong the operation. This risk is specific to the intraoperative environment and does not affect the device after implantation.
Patients who have received the recalled tibial components during surgery are most at risk. The recall applies to orthopedic implants used in joint replacements.
Check the model number on the device: Small (W 16-2817/02), Medium (W 16-2817/05), or Large (W 16-2817/07). The recall includes specific serial/lot numbers and UDI-DI codes listed in the official notice.
Reach out to your orthopedic surgeon to discuss the recall and necessary steps for the tibial component.
No, the recall does not require stopping use. The device is safe for use after implantation, but the hazard occurs during surgery.
The affected model numbers are Small (W 16-2817/02), Medium (W 16-2817/05), and Large (W 16-2817/07).
Check the model number on the device and compare it to the listed model numbers: Small (W 16-2817/02), Medium (W 16-2817/05), or Large (W 16-2817/07).
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-1379-2022 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1379-2022 from Waldemar Link. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
