waldemar link gmbh & co. kg (mfg site)medicalHigh PriorityActive

Endo-Model Replacement Plateau; Item Number: 15-8521/11;

Endo-Model Replacement Plateau; Item Number: 15-8521/11; was recalled because the potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.. If you have this product, stop using it until you verify your lot or model details.

By RecallRadar Editorial Team

Sourced from FDA. Last verified April 6, 2026.

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Key facts

Date announced
March 18, 2026
Source agency
FDA

This recall involves safety concerns. Take action promptly.

Plain-English Summary

Endo-Model Replacement Plateau; Item Number: 15-8521/11; was recalled because the potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.. If you have this product, stop using it until you verify your lot or model details.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

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

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand
Waldemar link gmbh & co. kg (mfg site)
Category
medical
Source agency
FDA
Announced
March 18, 2026
Country
US
Status
Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Item Number: 15-8521/11; UDI-DI: 04026575383245; Serial/Lot Number: 250728/2220, 250728/2222, 250728/2223, 250728/2224, 250728/2225, 250728/2226, 250728/2227;

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

  1. 1Stop using the affected product until you verify whether your item is impacted.
  2. 2Check the official recall notice and match your model, lot, or serial details.
  3. 3Follow the official instructions for repair, replacement, refund, or disposal.
Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
FDA
Announced by source
March 18, 2026
Last reviewed by RecallRadar
April 6, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists Item Number: 15-8521/11; UDI-DI: 04026575383245; Serial/Lot Number: 250728/2220, 250728/2222, 250728/2223, 250728/2224, 250728/2225, 250728/2226, 250728/2227;.

What is the remedy for this recall?

Follow the official instructions for repair, replacement, refund, or disposal on the waldemar link gmbh & co. kg (mfg site) recall page.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/device/enforcement.json?search=recall_number:Z-1519-2026&limit=1

Keep browsing with these internal hubs: waldemar link gmbh & co. kg (mfg site) recall hub and Medical recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from FDA

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