Waldemar Link recalls Endo-Model replacement sets with incorrect Pure Hinge plateau that may require surgery changes and increase implant wear risk. Affected items have specific item numbers and lot codes.
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
Waldemar Link is recalling Endo-Model replacement sets for Rotating Hinge tibial plates because they contain the wrong plateau type. Using these could lead to surgery changes or increased implant wear over time.
The replacement set includes a Pure Hinge plateau instead of the correct type. This causes the plateau to be unusable during surgery, requiring alternative products and potentially increasing wear on the implant over time.
Orthopedic surgeons and patients who received the specific Endo-Model replacement set with item number 15-0027/16. Patients with the incorrect plateau may need surgery adjustments.
Check for item number 15-0027/16 on the packaging or label. The lot code for implants is 2604069. These products were sold with specific UDI-DI codes starting with 04026575432134.
Look for item number 15-0027/16 and lot code 2604069 on the packaging or label.
The affected replacement sets contain a Pure Hinge plateau instead of the correct type, which can't be inserted during surgery and may require alternative products.
Using the incorrect plateau could lead to surgery changes and increased implant wear, reducing how long the implant can last.
Check for item number 15-0027/16 and lot code 2604069 on the packaging or label.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-2934-2026 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-2934-2026 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.
