Class II U.S. Food and Drug Administration

Waldemar Link GmbH & Co. KG Endo-Model SL Connection Component incl. PE-Plateau recall: The potential for an implant with a plateau screw where the bushing

Recall published 7 months ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1511-2026
Published
March 18, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Waldemar Link GmbH & Co. KG
Product type
Medical devices
Units affected
44 units (1 US, 43 OUS)
Distribution
Nationwide
Made in
Germany
Lot / code info
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;
UPC codes
04026575359240

Products covered by this recall

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 04026575359240

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 250513
  • 2083
  • 2085
  • 2086
  • 2089
  • 2090
  • 25051

Model or item number

On the rating label, the box or the instruction sheet.

  • 16-2840
  • 05

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Waldemar Link GmbH & Co. KG — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Waldemar Link GmbH & Co. KG (Mfg Site) — Ost Str. 4-10, Norderstedt

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Waldemar Link GmbH & Co. KG medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04026575359240; lot code 250513, 2083, 2085; model number 16-2840, 05. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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