The Recall Desk
HighFDA (Devices)·Z-1513-2026·Announced 2026-03-18

Link Endo-Model SL component 16-2840/02 recalled over bushing fracture

Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/02 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a component of an implant could fracture and detach, and no injuries are stated in the source.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling the Endo-Model SL Connection Component including PE-Plateau, item number 16-2840/02. About 49 units were distributed, all outside the United States, as part of a campaign covering New Jersey and Belarus, Canada, Switzerland, Colombia, Germany, Spain, the United Kingdom, Hungary, India, Italy, the Netherlands, Romania and Saudi Arabia. The FDA has classified this recall as Class II.

There is the potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Affected product carries UDI-DI 04026575359233, across 49 serial/lot numbers beginning 250925/0639.

Facilities can identify affected implants by the item number, UDI and serial numbers above, and may contact Waldemar Link GmbH & Co. KG for further information.

The recalled product

Product
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopaedic implant
Hazard
Affected units
49

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 (20)

  • Item Number: 16-2840/02
  • UDI-DI: 04026575359233
  • Serial/Lot Number: 250925/0640
  • 250925/0641
  • 250925/0642
  • 250925/0646
  • 250925/0650
  • 250925/0652
  • 250925/0653
  • 250925/0656
  • 250925/0658
  • 250925/0669
  • 250925/0670
  • 250925/0680
  • 250925/0681
  • 250925/0682
  • 250925/0687
  • 250925/0689
  • 250925/0690
  • 250925/0691

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 13 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Related recalls

Same manufacturer · Waldemar Link GmbH & Co. KG (Mfg Site)

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Same hazard · implant fracture

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