Recall Z-2054-2020 ยท GXP Methyl Methacrylate For Cranioplasty
Skeletal Kinetics, Llc
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger than 25cm2. CRANIO/SCULPT C may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.
| Date | Apr 3, 2020 |
| Status | Terminated |
| Reason | Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc. |
| Root cause | Process design |
| Action | The recalling firm notified their customer regarding the medical device recall via email; the recall notice was issued on 04/03/2020. The recalling firm is requesting that affected customers: (1) review the letter in full, review current inventory, and complete and return the Acknowledgement and Receipt Form via email; and (2) return unused inventory via Federal Express (contact the recalling firm for a FedEx shipping account number to cover shipping costs) with reference to Return Material Authorization RMA# 8. If there has been further distribution of the affected devices to other subaccou |
| Quantity | 125 units |
| Distribution | US Nationwide distribution in the state of Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162864 | OsteoVation Impact Skeletal Kinetics, LLC, Jan 13, 2017 |