FDAFDA · Food and drugs·Recall number Z-2965-2018
Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.
Published September 12, 2018 · Recall initiated: July 12, 2018
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
A size 22mm threaded peg was found in the package of a 10mm unit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- International Distribution to countries of: Japan and Netherlands.
- Lot
- Lot 969440; UDI (01)00887868012310(17)280309(10)969440
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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