FDAFDA · Food and drugs·Recall number Z-1800-2015
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.
Published June 24, 2015 · Recall initiated: May 13, 2015
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
Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Part Numbers: 02.240.044, 02.240.244, Lot Numbers 8886011, 8886046
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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