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 00846832092192Lot 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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