Recall Weekly
Moderate riskFDA DeviceClass II

Waldemar Link Endo-Model SL Connection Component recalled for potential bushing detachment

Waldemar Link GmbH & Co. KG is recalling specific lots of the Endo-Model SL Connection Component with PE-Plateau (Item 16-2840/07) used in orthopedic implants. The bushing on the plateau screw could detach from the screw shaft due to a longitudinal fracture, which could affect implant stability. Thirty-one units have been distributed outside the US.

From the FDA notice · Read the official notice ↗ · All Waldemar Link recalls

What to do

  1. Check if you received this implant by verifying the lot number against the recall list (250925/0480, 0481, 0482, etc.)
  2. Contact your surgeon or Waldemar Link immediately if you have one of the affected lot numbers
  3. Do not use affected lots for new implant procedures
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 13 products — see all of them.

Details

Units affected
31 units (OUS only)
Illnesses reported
None reported
Manufactured in
Ost Str. 4-10, N/A, Norderstedt, N/A, Germany
Classification
Class II
Recall number
Z-1514-2026

In the FDA's words

Description
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Item Number: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367; Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia. Affected quantity: 31 units (OUS only)
Hazard
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

13 products in this recall

Waldemar Link Endo-Model implant parts recalled for fracture risk

Waldemar Link is recalling 13 Endo-Model implant components, including replacement plateaus and connection components with PE-Plateau. The bushing on these implants could detach from the screw shaft because of a longitudinal fracture. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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