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Lower risk Medical device recall · FDA · Published February 11, 2026

Embrace Drill Tower Wedged (25mm) Recall: Mixed-up Article Numbers in Surgical Technique

Waldemar Link recalls Embrace Drill Tower Wedged (25mm) due to mixed-up article numbers in surgical technique documentation, which could lead to incorrect instrument usage during procedures.

🇺🇸 FDA recall #Z-1651-2026Medical deviceWaldem: Embrace ›
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Recalling firmWaldemar Link GmbH & Co. KG (Mfg Site)Ost Str. 4-10 · Norderstedt, Germany
✎ GovInfoNow plain-language explainer

Waldemar Link is recalling Embrace Drill Towers with wedged (25mm) models because the surgical technique documentation contains mixed-up article numbers. This could lead to incorrect instrument usage during procedures if the wrong items are selected. Read more at govinfonow.com/recall/50020-embrace-drill-tower-wedged-25mm-recall-mixed-up-article-numbers.

Source Summary by GovInfoNow · govinfonow.com/recall/50020-embrace-drill-tower-wedged-25mm-recall-mixed-up-article-numbers · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1651-2026

Cite this page

“Embrace Drill Tower Wedged (25mm) Recall: Mixed-up Article Numbers in Surgical Technique.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50020-embrace-drill-tower-wedged-25mm-recall-mixed-up-article-numbers. Based on FDA recall #Z-1651-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1651-2026%22&limit=1).

Waldemar Link GmbH & Co. KG recalled Embrace Drill Tower, Wedged (25mm) instruments due to mixed-up article numbers in the instrument overview, according to the FDA on Feb. 11, 2026. The agency classified the Class II recall as voluntary.

How to tell if you have it

  • Brand: Waldem: Embrace
  • Product: Embrace Drill Tower, Wedged (25mm)
  • Item Number: 645-081/62
  • UDI: 04026575534715
  • Lot Number: All Lots
  • Units affected: 75

The hazard

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

Context

GovInfoNow's records show Waldemar Link GmbH & Co. KG (Mfg Site) has 21 other recalls on record since Dec. 4, 2018. Other recent recalls of similar products include XTANT Medical Xpress Pedicle Screw System: Incorrect Labeling Risk (Feb. 18, 2026) and Encore Medical EMPOWR Acetabular System Recall: Packaging Discrepancy May Cause Surgical Delays (Jan. 5, 2026).

How to tell if you have this one

Check for the item number 645-081/62 on the Embrace Drill Tower Wedged (25mm). The product was sold with all lots and has a UDI of 04026575534715.

  • Brand
    Waldem: Embrace
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
Recall numberProduct, codes & lotsQuantity
Z-1651-2026Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;; Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;75 units
Z-1652-2026Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;; Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;74 units
Based on the official FDA remedy

What to do — step by step

  1. Check Documentation

    Review the surgical technique documentation for correct article numbers to ensure proper instrument selection.

Where it went and when

Where it was distributed

Distributed in 15 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: yesKYWest Virginia: not listedWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, North Carolina, Ohio, Oklahoma, Texas, Virginia.

Recall timeline

FDA published this recall 49 days after the firm started it.

1. Firm started the recall: Feb 11, 202612. FDA classified it Class II: Mar 26, 202623. Published in FDA’s Enforcement Report: Apr 1, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this recall affecting my surgery?

The recall is for the surgical technique documentation, not the physical product. It does not affect ongoing surgeries but may require verification of instrument numbers before future procedures.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1651-2026 (February 11, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1651-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA