FDAFDA · Food and drugs·Recall number Z-3309-2024
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Published October 9, 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
Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Tornier, Inc
- Distributor
- US Nationwide distribution.
- Lot
- GTIN 00846832084494, Batch Lot # 1495AY
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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