FDAFDA · Food and drugs·Recall number Z-2407-2018
Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
Published July 18, 2018 · Recall initiated: April 27, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker GmbH
- Distributor
- The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
- Lot
- GTIN: 04546540673398; Lot code: K078C7E
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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