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Lower risk Medical device recall · FDA · Published January 29, 2024

Embrace Drill Tower Wedged (25mm) Recall: Mixed-up Surgical Instrument Types

Waldemar Link recalls Embrace Drill Tower Wedged (25mm) surgical instruments due to mixed-up type descriptions in the product manual, potentially causing confusion in surgical procedures.

🇺🇸 FDA recall #Z-1257-2024Medical deviceWaldem: Embrace ›
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Contact the company

Recalling firmWaldemar Link GmbH & Co. KG (Mfg Site)Oststr. 4-10 · Norderstedt, Germany
✎ GovInfoNow plain-language explainer

Waldemar Link is recalling Embrace Drill Tower Wedged (25mm) surgical instruments because the product manual incorrectly mixes up 'standard' and 'wedged' type descriptions. This could lead to confusion during surgical procedures, though it does not pose an immediate safety risk. Read more at govinfonow.com/recall/56230-embrace-drill-tower-wedged-25mm-recall-mixed-up-surgical-instrument.

Source Summary by GovInfoNow · govinfonow.com/recall/56230-embrace-drill-tower-wedged-25mm-recall-mixed-up-surgical-instrument · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1257-2024

Cite this page

“Embrace Drill Tower Wedged (25mm) Recall: Mixed-up Surgical Instrument Types.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56230-embrace-drill-tower-wedged-25mm-recall-mixed-up-surgical-instrument. Based on FDA recall #Z-1257-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1257-2024%22&limit=1).

The FDA announced on Jan. 29, 2024, that Waldemar Link GmbH & Co. KG is recalling Embrace Drill Tower, Wedged (25mm) surgical instruments due to mixed-up type descriptions in the surgical techniques. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Waldem: Embrace
  • Product: Embrace Drill Tower, Wedged (25mm)
  • Item Number: 645-081/62
  • UDI/DI: 04026575534715
  • Quantity: 6 units
  • Distribution: US Nationwide distribution in the states of AL and LA

The hazard

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments, according to the FDA.

Context

GovInfoNow's records show Waldemar Link GmbH & Co. KG (Mfg Site) has 21 other recalls on record since 2018-12-04. Other recent recalls of similar products include XTANT Medical Xpress Pedicle Screw System (2026-02-18), Olympus HX-400U-30 Ligating Device Recall (2025-10-30), and Tornier Perip Screw Recall (2025-12-19).

How to tell if you have this one

Check for item numbers 645-081/62 on the Embrace Drill Tower Wedged (25mm) instruments. All lots of these instruments were recalled due to mixed-up type descriptions in the product manual.

  • 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 Nationwide distribution in the states of AL and LA.
Recall numberProduct, codes & lots
Z-1257-2024Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; UDI/DI: 04026575534715; All lots of the LINK Embrace Drill Tower surgical instruments.
Z-1258-2024Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; UDI/DI: 04026575534722; All lots of the LINK Embrace Drill Tower surgical instruments.
Based on the official FDA remedy

What to do — step by step

  1. Check Product Manual

    Review the product manual for mixed-up descriptions of 'standard' and 'wedged' types to confirm if the instrument is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of AL and LA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Louisiana.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: Jan 29, 202412. FDA classified it Class II: Mar 6, 202423. Published in FDA’s Enforcement Report: Mar 13, 202432024
  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.

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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-1257-2024 (January 29, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1257-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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