Reported Sep 25, 2024 · Ongoing

stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the…

Tornier, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Tornier, Inc · 10801 Nesbitt Ave S · Bloomington, MN · 55437-3109

Is this the product you have?

  • stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Lot codes and dates
    • UDI/DI 00846832092192
    • Lot number 3268BA
Amount recalled
5 units

Where it was sold

Why it was recalled

One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.