Z-2593-2020 Class II Terminated
FDA device recall Z-2593-2020 was initiated by Skeletal Kinetics, Llc on April 6, 2020 and is designated Class II. 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-te… The recall status is terminated (terminated February 24, 2021). Affected quantity: 184.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2020
- Initiation Date
- April 6, 2020
- Termination Date
- February 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 184
Product Description
ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - 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.
Distribution Pattern
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.
Code Information
Lot Numbers: 17091305, 17091304, 17091303, 17101916, 17110325, 1126148, 1129604, 1135939.