FDAFDA · Food and drugs·Recall number Z-3155-2024
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Published September 25, 2024 · Recall initiated: August 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Tornier, Inc
- Distributor
- US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
- Lot
- UDI/DI 00846832092192, Lot number 3268BA
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.