FDAFDA · Food and drugs·Recall number Z-2054-2020
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger than 25cm2. CRANIO/SCULPT C may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.
Published May 27, 2020 · Recall initiated: April 3, 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
Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Skeletal Kinetics, Llc
- Distributor
- US Nationwide distribution in the state of Florida.
- Lot
- Lot 1129289
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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