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BfArM publishes Stryker Spine field safety notice for ES2 Spinal System Nitinol K+-Wire Blunt

🇩🇪 BfArM field safety notices · Thu 22 Oct 2026

Germany's medicines and devices regulator has posted an urgent field safety notice from Stryker Spine-US on a spinal surgery wire, but the listing itself gives no details of the problem.

The German Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from Stryker Spine-US concerning the ES2 Spinal System Nitinol K+-Wire Blunt. The entry is dated 22 October 2026 and carries the reference 49141/26.

BfArM files the notice under the product group "Injections / Infusions / Transfusions / Dialysis - injection kits". The listing does not describe the nature of the defect or risk, the affected lots or serial numbers, or the actions the manufacturer is asking users to take.

Instead, BfArM refers readers to the manufacturer's Advisory Notice, which is attached as a PDF of about 1 MB. Anyone needing specifics on the issue and the corrective measures will have to consult that document directly.

As general context, a field safety notice is the communication a manufacturer sends to customers when it takes a field safety corrective action on a medical device already on the market, and national authorities such as BfArM make these notices publicly available.

What it means for your team

  • Quality and regulatory teams at hospitals and distributors handling the ES2 Spinal System should obtain and read the full manufacturer Advisory Notice, as the BfArM listing contains no detail on the issue.
  • Check whether the device is held in inventory or used in surgical procedures, and follow the actions set out by Stryker Spine-US in the notice.
  • Vigilance teams should log the notice under BfArM reference 49141/26 for traceability.

Official source: BfArM field safety notices ↗

Article written by VigiEye from the official source (BfArM field safety notices). AI-assisted; check the source before acting.

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