Device product
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.
Z-2054-2020
Product summary
- Event
- Event 85516
- Status
- Terminated
- Classification
- Class II
- Quantity
- 125 units
- Official record key
device-enforcement:Z-2054-2020
Official wording
Reason: 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.
Code information: Lot 1129289
Distribution pattern: US Nationwide distribution in the state of Florida.
Derived failure modes
-
Unknown
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.