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 (Item 16-2840/05) used in orthopedic implants. A bushing on the plateau screw could detach from the screw shaft due to a crack, which could affect implant stability. One unit was distributed in the U.S. (New Jersey); the remaining 43 units were distributed internationally.

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

What to do

  1. Contact your surgeon or healthcare provider immediately if you received this implant component
  2. Check the lot number on your implant documentation against the FDA recall list
  3. Do not use any inventory of this component if you are a healthcare facility
  4. Report any problems with your implant to the FDA MedWatch program
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: 16-2840/05;
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 13 products — see all of them.

Details

Units affected
44 units (1 US, 43 OUS)
Illnesses reported
None reported
Manufactured in
Ost Str. 4-10, N/A, Norderstedt, N/A, Germany
Classification
Class II
Recall number
Z-1511-2026

In the FDA's words

Description
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; 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: 16-2840/05; UDI-DI: 04026575359240; Serial/Lot Number: 250513/2083, 250513/2085 , 250513/2086, 250513/2089, 250513/2090, 250513/2092, 250513/2093, 250513/2097 , 250513/2100, 250513/2102, 250513/2104, 250513/2107, 250513/2108, 251013/3245 , 251013/3247, 251013/3250, 251013/3251, 251013/3252, 251013/3253, 251105/0013 , 251105/0016, 251105/0018, 251105/0020, 251105/0032, 251105/0034, 251105/0036 , 251105/0037, 251105/0038, 251105/0039, 250513/2106, 250513/2099, 251105/0014 , 251105/0040, 251105/0002, 250513/2087, 250513/2091, 251013/3246, 251105/0019 , 251013/3249, 251105/0011, 251105/0012, 250513/2103, 250513/2105, 251013/3254; 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: 44 units (1 US, 43 OUS)
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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