FDAFDA · Food and drugs·Recall number Z-2383-2020
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Published June 24, 2020 · Recall initiated: May 7, 2020
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
Seal integrity of the blister pack may be compromised and sterility cannot be assured
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker GmbH
- Distributor
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- Lot
- Lot Number: K029C38, K029C39, K030EF6, K030EF7, K030EF9, K031B66
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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