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U.S. Department of Health and Human Services

Class 2 Device Recall CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEOVATION

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  Class 2 Device Recall CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEOVATION see related information
Date Initiated by Firm April 06, 2020
Create Date July 15, 2020
Recall Status1 Terminated 3 on February 24, 2021
Recall Number Z-2596-2020
Recall Event ID 85517
510(K)Number K100986  
Product Classification Filler, bone void, calcium compound - Product Code MQV
Product ACUMED IMPACT 5CC.
Product Number: 65-0105-S, UDI: 813845020252 - 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.
Code Information Lot Numbers: 1126150, 1128790, 1136332.
Recalling Firm/
Manufacturer		 Skeletal Kinetics, Llc
3885 Arapaho Rd
Addison TX 75001-4314
For Additional Information Contact Ms. Kathryn Jayne
972-677-4602
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 04/06/2020, the firmed notified affected customers via email and/or facsimile of "URGENT Medical Device Recall" letter. The letter indicated actions to be taken by the customers and Clinical Providers. For affected customers, the firm is requesting that affected customers: (1) review this letter in full, review current inventory, and complete and return the "Acknowledgement and Receipt Form" via email, recall@skeletalkinetics.com; and (2) return unused inventory via Federal Express with reference to Return Material Authorization. If you have further distributed any of the affected devices to other subaccounts, please communicate this recall information immediately and conduct a sub-recall to those accounts. Please request that they immediately cease distribution of the affected devices and promptly return the product to you. Subsequently, contact the firm for instructions on returning the recalled product you receive from your subaccounts. For affected Health Care Providers, the firm is requesting the following: For any patient that may have been implanted with recalled product, we recommend that healthcare providers use judgement regarding patient follow-up. If the patient shows signs of incomplete bone formation or lack of bone formation, delayed union, or nonunion, the appropriate clinical measures should be taken based on the individual patient circumstances. If the patient experienced adequate healing, there is no reason to believe that there would be any additional concerns with the product. Report any adverse health consequences or quality problems experienced with the use of the product to the firm at 972-677-4600. For questions regarding the recall, contact the firm via email at recall@skeletalkinetics.com.
Quantity in Commerce 41
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = SKELETAL KINETICS, LLC
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