FDAFDA · Food and drugs·Recall number Z-0837-2018
STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Published March 14, 2018 · Recall initiated: November 17, 2017
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
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Corporation
- Distributor
- Distributed domestically to . Distributed internationally to Australia and Mexico.
- Lot
- Model 0234010056, UDI 04546540754561, Lot No. 17278AG2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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