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Endo-Model Replacement Plateau
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MEDICAL DEVICE RECALLMODERATE

Endo-Model Replacement Plateau

Endo-Model Replacement Plateau is recalled due to a risk of bushing detachment from the screw shaft caused by longitudinal fractures.

What to do

Stop using the affected implant components and contact your healthcare provider or the manufacturer for further instructions regarding replacement or monitoring.

Recalled
Listed
Updated
Recall No.
Z-1517-2026
Agency
FDA
Firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Recall ID
98342
Status
ONGOING

Why it was recalled

The Endo-Model Replacement Plateau is being recalled due to the risk of the bushing detaching from the screw shaft caused by a longitudinal fracture. This issue affects units with item number 15-0027/11 and 15-0027/16. The product was distributed nationwide.

Is mine affected?

This recall covers 13 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
Endo-Model Replacement Plateau; Item Number: 15-8030/12;Z-1517-202604026575048151
Endo-Model Replacement Plateau; Item Number: 15-0027/11;Z-1521-202604026575431953
Endo-Model Replacement Plateau; Item Number: 15-8521/15;Z-1520-202604026575383283
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;Z-1511-202604026575359240
Endo-Model Replacement Plateau; Item Number: 15-0027/15;Z-1512-202604026575432127
Endo-Model Replacement Plateau; Item Number: 15-2835/12;Z-1515-202604026575316564
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;Z-1514-202604026575359257
Endo-Model Replacement Plateau; Item Number: 15-2836/11;Z-1516-202604026575316571
Show all 13 products
ProductRecall #UDI-DI
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;Z-1513-202604026575359233
Endo-Model Replacement Plateau; Item Number: 15-8521/09;Z-1518-202604026575383238
Endo-Model Replacement Plateau; Item Number: 15-8521/11;Z-1519-202604026575383245
Endo-Model Replacement Plateau; Item Number: 15-0027/16;Z-1523-202604026575432134
Endo-Model Replacement Plateau; Item Number: 15-0027/12;Z-1522-202604026575431960

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-07-10 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification