Recall Z-2635-2020 ยท GXP Methyl Methacrylate For Cranioplasty
Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - 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 intri
| Date | Apr 6, 2020 |
| Status | Terminated |
| 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. |
| Root cause | 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 device |
| Quantity | 51 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162864 | OsteoVation Impact Skeletal Kinetics, LLC, Jan 13, 2017 |