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Use caution Medical device recall · FDA · Published December 18, 2024

Tornier Stryker Blueprint Glenoid Pin Guide Recall: Pin Guide May Disassemble

Tornier recalls Stry: Blueprint Mixed Reality Glenoid Pin Guide (MRUE200) due to risk of disassembly during surgery, potentially prolonging procedures. Affected units have specific lot numbers.

🇺🇸 FDA recall #Z-0846-2025Medical deviceTornier ›
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Recalling firmTornier S.A.S.161 Rue Lavoisier · Montbonnot-Saint-Martin, France
✎ GovInfoNow plain-language explainer

Tornier is recalling Stryker Blueprint Mixed Reality Glenoid Pin Guides (model MRUE200) because the metal tube might separate from the plastic handle. This could cause the headset to fail during surgery, leading to longer procedures or changes in surgical technique. Read more at govinfonow.com/recall/53280-tornier-stryker-blueprint-glenoid-pin-guide-recall-pin-guide-may.

Source Summary by GovInfoNow · govinfonow.com/recall/53280-tornier-stryker-blueprint-glenoid-pin-guide-recall-pin-guide-may · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0846-2025

Cite this page

“Tornier Stryker Blueprint Glenoid Pin Guide Recall: Pin Guide May Disassemble.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/53280-tornier-stryker-blueprint-glenoid-pin-guide-recall-pin-guide-may. Based on FDA recall #Z-0846-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0846-2025%22&limit=1).

Tornier S.A.S. recalled the Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200, because its metal tube may disassemble from the plastic handle, according to the FDA. The Food and Drug Administration announced the Class II recall on Dec. 18, 2024.

How to tell if you have it

  • Brand: Tornier
  • Product: Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide
  • REF: MRUE200
  • UDI/DI: 03700434022926
  • Lot Numbers: 22A796, 22A797, 22A978, 22A979
  • Units affected: 24

The hazard

The metal tube may disassemble from the plastic handle, which can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide. This potential failure may prolong surgery time or require a change of surgical method from guided to conventional.

Context

GovInfoNow's records show Tornier S.A.S. has issued four other recalls since June 25, 2021. Recent brand recalls include the April 16, 2024, Tornier Stryker Blueprint Software Recall for incompatible implant configurations and the March 5, 2025, Tornier Blueprint Mixed Reality Depth Stop Pin Recall. Other recent recalls of similar products include the May 20, 2026, Zimmer Off-Axis Shoulder System Recall and the May 20, 2026, Zimmer Off-Axis Alliance Glenoid Reamer Guide Recall.

How to tell if you have this one

Check for the model number MRUE200 on the device. Affected units have lot numbers 22A796, 22A797, 22A978, or 22A979. The product was sold for total shoulder arthroplasty procedures.

  • Brand
    Tornier
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Status

    Verify if the pin guide's metal tube is securely attached to the plastic handle.

  2. Contact Manufacturer

    Reach out to Tornier for guidance on next steps if the device is affected.

Where it went and when

Where it was distributed

Distributed in 7 states, and outside the U.S.

Alaska: yesAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: yesIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: yesKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alaska, Idaho, Kentucky, Maryland, Massachusetts, Minnesota, Texas.

Recall timeline

FDA published this recall 35 days after the firm started it.

1. Firm started the recall: Dec 18, 202412. FDA classified it Class II: Jan 10, 202523. Published in FDA’s Enforcement Report: Jan 22, 2025320242025
  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-0846-2025 (December 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0846-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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