FDAFDA · Food and drugs·Recall number Z-2105-2023
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Published July 12, 2023 · Recall initiated: June 13, 2023
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
The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Wright Medical Technology, Inc.
- Distributor
- There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
- Lot
- Lot numbers 2656815 and 2762126, UDI-DI 00889797003926.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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