Recall Z-2600-2020— Skeletal Kinetics, Llc

Name: FDA recall Z-2600-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-06

Class II · Terminated

Class II FDA medical device recall by Skeletal Kinetics, Llc, initiated 2020-04-06, terminated 2021-02-24. It names one FDA 510(k) clearance: K042072. Product: CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.. Reason: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion..

Recalling firm: Skeletal Kinetics, Llc
Classification: Class II
Status: Terminated
Initiated: 2020-04-06
Terminated: 2021-02-24
Firm location: Addison, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K042072 — CALLOS CMF BONE VOID FILLERSkeletal Kinetics, LLC·cleared 2004-09-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Reason for recall

Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

Data sourced from openFDA. This site is unofficial and independent of the FDA.