medical MODERATE Updated 2026-08-19

Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model, Replacement Set, Tibial Plateau, right/left, L,

See all recalls from Waldemar Link GmbH & Co. KG (Mfg Site) →

Recalled Product

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

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.

Issued by

FDA

Distribution: Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
Lot/Code Info: UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Endo-Model, Replacement Set, Tibial →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Related medical Recalls

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Rystem, Model Numbers: 722063, 722064, 722

2026-08-19 · Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

BioFire Diagnostics, LLC recalls BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code:

2026-08-19 · Due to increase in false negative results

OBP Medical Corporation recalls OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED L

2026-08-19 · There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

Covidien, LP recalls Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 888617

2026-08-19 · Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.