PlainRecalls
FDA Devices Moderate Class II Terminated

SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - 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

Reported: July 22, 2020 Initiated: April 6, 2020 #Z-2625-2020

Product Description

SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - 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.

Details

Recalling Firm
Skeletal Kinetics, Llc
Units Affected
12
Distribution
Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, WI and the countries of Australia, Canada, South Africa, Switzerland.
Location
Addison, TX

Frequently Asked Questions

What product was recalled? ▼
SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - 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.. Recalled by Skeletal Kinetics, Llc. Units affected: 12.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 22, 2020. Severity: Moderate. Recall number: Z-2625-2020.

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