Z-2054-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- April 3, 2020
- Termination Date
- January 30, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the state of Florida.
Code Information
Lot 1129289