medical Class II Updated 2024-09-25

Tornier, Inc recalls stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomi

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI 00846832092192, Lot number 3268BA
View official government recall

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