Reported May 27, 2020 · Terminated
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate…
Skeletal Kinetics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Skeletal Kinetics, Llc · 3885 Arapaho Rd · Addison, TX · 75001-4314
Is this the product you have?
- Cranio/Sculpt C, 10cc, Bone Void Filler
- UDI00813845021129 -
- Product UsageCRANIO/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
- Lot codes and dates
- Lot 1129289
- Amount recalled
- 125 units
Where it was sold
- Nationwide
- FL
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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