Skeletal Kinetics, Llc: Medical Device Recall in 2020 - (Recall #: Z-2054-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 3, 2020

Date Posted: May 27, 2020

Recall Number: Z-2054-2020

Event ID: 85516

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.

Status: Terminated

Product Quantity: 125 units

Code Information:

Lot 1129289

Distribution Pattern:

US Nationwide distribution in the state of Florida.

Voluntary or Mandated:

Voluntary: Firm initiated