Waldemar Link recalls specific orthopedic prosthesis models due to risk of blind screws that cannot be loosened during surgery, potentially prolonging procedures. Affected models include Small (W 16-2817/32), Medium (W 16-2817/35), and Large (W 16-2817/37).
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 specific orthopedic prosthesis models because blind screws in the tibial component may not loosen during surgery, leading to longer procedures. This recall affects surgeons and hospitals using the recalled models.
The blind screws in the modular tibial component may not loosen properly during surgery. This could require surgeons to change procedures mid-operation, prolonging the surgery time and potentially increasing risks for patients.
Surgeons and hospitals that use the recalled Tibial Component Modular orthopedic prosthesis models are most at risk. The recall applies to specific model sizes and production batches.
Check the model number on the prosthesis: Small (W 16-2817/32), Medium (W 16-2817/35), or Large (W 16-2817/37). Also look for the UDI-DI codes: 04026575370870 for Small, 04026575370887 for Medium, or 04026575370894 for Large.
Identify the model number on the prosthesis: Small (W 16-2817/32), Medium (W 16-2817/35), or Large (W 16-2817/37).
Check the UDI-DI code: 04026575370870 for Small, 04026575370887 for Medium, or 04026575370894 for Large.
The blind screws in the modular tibial component may not loosen properly during surgery, which could require changing procedures mid-operation and prolong surgery time.
Small (W 16-2817/32), Medium (W 16-2817/35), and Large (W 16-2817/37).
Check the model number and UDI-DI code: Small (W 16-2817/32) has UDI-DI 04026575370870, Medium (W 16-2817/35) has 04026575370887, and Large (W 16-2817/37) has 04026575370894.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-1380-2022 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1380-2022 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.
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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.
