The Recall Desk
HighFDA (Devices)·Z-2411-2024·Announced 2024-07-24

Endo Model SL Tibial Components Recalled for Inoperable Blind Screws

Waldemar Link is recalling Endo Model SL Tibial Components used in knee replacement surgery because the blind screws on the modular components cannot be loosened during surgery, potentially prolonging procedures and forcing surgeons to change their planned approach.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported hospitalizations or injuries, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.' The defect creates risk of intraoperative complications during knee replacement surgery, but no actual harm has been documented.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling Endo Model SL Tibial Components, which are used as part of knee replacement surgery implants. The affected components include multiple sizes (small, medium, and large) in both standard and modular versions, with model numbers 16-2817/02, 16-2817/05, 16-2817/07, 16-2817/32, 16-2817/35, and 16-2817/37. All units manufactured since June 1, 2022, are affected.

The blind screws on the modular tibial components cannot be loosened during surgery as intended. This prevents surgeons from making necessary adjustments intraoperatively and can prolong the surgery duration. In some cases, the defect forces surgeons to change their planned surgical procedure, potentially requiring alternative cementing techniques. This creates a risk that the implant may not be positioned or secured optimally.

A total of 114 units have been distributed in the United States, with an additional 2,351 units distributed internationally across multiple countries. Patients who have already received these implants and surgeons preparing to use inventory of these components should be aware of this issue.

Patients with questions about their implant should contact their orthopedic surgeon. Healthcare providers with inventory of these components should stop using them and contact Waldemar Link or the FDA for guidance on replacement or remediation.

The recalled product

Product
Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medi
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopedic Implant / Knee Replacement
Hazard
  • surgical-complication
  • device-malfunction
  • design-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Product UDI-DI 16-2817/02 04026575359202
  • 16-2817/05 04026575359219
  • 16-2817/07 04026575359226
  • 16-2817/32 04026575370870
  • 16-2817/35 04026575370887

Distribution

Distributed nationwide across the United States.

Related recalls

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