HIGH

Waldemar Link Embrace Drill Tower Recall 74 Units in 2026

Waldemar Link GmbH & Co. KG recalls 74 Embrace Drill Tower devices distributed in 15 U.S. states. The recall notes mixed-up article numbers in the overview of the instruments. The surgical steps are correct. Stop using the device immediately and follow manufacturer instructions.

Quick Facts at a Glance

Recall Date
February 11, 2026
Hazard Level
HIGH
Brand
Waldemar Link GmbH & Co. KG
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
Nationwide (50 states)
At-Risk Groups
GENERAL

Hazard Information

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

The Embrace Shoulder Instruments are used in orthopedic shoulder procedures. The Drill Tower is a component used during surgical steps.

Why This Is Dangerous

A mismatch between article numbers in the instrument overview may lead to incorrect instrument identification during procedures. The steps remain correct, but mislabeling could affect device selection.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

74 devices recalled in the United States across 15 states. Immediate action required to prevent potential procedural errors.

Practical Guidance

How to identify if yours is affected

  1. Verify item numbers against the recall notice: 645-081/63 and 645-081/62.
  2. Check UDI 04026575534715 for mislabeling alerts.
  3. Review the recall email from Waldemar Link for instructions.

Where to find product info

FDA enforcement report page for Z-1652-2026 provides the official recall notice.

What timeline to expect

No specific refund timeline provided in the notice.

If the manufacturer is unresponsive

  • Escalate to Waldemar Link via email, if available.
  • Coordinate with your healthcare facility for guidance and possible alternatives.

How to prevent similar issues

  • Verify instrument labeling before use.
  • Cross-check item numbers with official recall notices.
  • Maintain updated records of instrument configurations in surgical kits.

Documentation advice

Keep recall notice, email communications, and any replacement instructions for records.

Product Details

Model numbers: 645-081/63 (primary) and 645-081/62 (related). UDI: 04026575534715. Sold in the United States to AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA. Recall date: 2026-02-11. Quantity: 74 units. Status: ACTIVE.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Quantity recalled: 74 units
  • US distribution states: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
  • Item Numbers: 645-081/63 and 645-081/62
  • UDI: 04026575534715
  • Recall status: ACTIVE
  • Hazard type: Mixed-up article numbers in instrument overview; surgical steps correct
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeDrill Tower (Surgical Instrument)
Sold At
Multiple Retailers

Product Details

Model Numbers
Item Number: Item Number: 645-081/62
UDI: 04026575534715
Lot Number: All Lots
Affected States
Nationwide
Report Date
April 1, 2026
Recall Status
ACTIVE

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