FDAFDA · Food and drugs·Recall number Z-1984-2014
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.
Published July 9, 2014 · Recall initiated: May 15, 2014
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
All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
- Lot
- All lots of part no. B37: 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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