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Urgent Enforcement Amended Final

Waldemar Link Embrace Drill Tower 25mm - Class II Recall

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Summary

FDA issued a Class II recall for Waldemar Link Embrace Drill Tower, Standard/Lateral (25mm) due to mixed-up article numbers in the surgical technique overview, though individual surgical steps are correct. The device was distributed to healthcare facilities in 15 U.S. states including AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, and VA.

What changed

FDA issued a Class II medical device recall for Waldemar Link Embrace Drill Tower, Standard/Lateral (25mm). The recall was initiated because the surgical technique documentation contains mixed-up article numbers in the instrument overview, though the individual surgical step descriptions remain correct. The affected device was distributed to healthcare providers across 15 states.

Healthcare facilities that received this device must review their inventory, verify instrument identification matches documentation, and update surgical technique guides as needed. While the actual surgical steps are unaffected, instrument misidentification could lead to procedural delays or errors if staff rely on the incorrect article numbers in the overview section.

What to do next

  1. Identify and quarantine affected Embrace Drill Tower units (Item No. 645-081/63)
  2. Verify surgical technique documentation matches actual instrument article numbers
  3. Report any adverse events related to instrument identification errors to FDA

Archived snapshot

Apr 10, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Waldemar Link GmbH & Co. KG (Mfg Site)

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1652-2026 · 20260401 · Ongoing

Product

Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

Reason for Recall

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.

Distribution

US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA

Source: openFDA Enforcement API

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Last updated

Classification

Agency
FDA
Filed
April 1st, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1652-2026

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Surgical instrument recall Device labeling correction
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Product Safety

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