Recall Z-2131-2026 ยท MQV Filler, Bone Void, Calcium Compound
Orthorebirth Co Ltd
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
| Date | May 7, 2026 (initiated Mar 25, 2026) |
| Status | Open, Classified |
| Reason | Resorbable bone void filler falls outside standard specifications. |
| Root cause | Device Design |
| Action | On 3/25/2026, product withdrawal emails were sent to customers informing them to stop distribution and that additional information on device return would be provided. If products were distributed to distributors or hospitals, the firm requests the customer inform to stop distribution and ensure affected devices are not used. In addition, notify the firm if affected devices were used in surgery. On 4/21/2026, recall notices were emailed to customers who were asked to do the following: 1) Return affected devices to firm. 2) If devices were distributed elsewhere, recover all affected product th |
| Quantity | 1266 |
| Distribution | US Nationwide distribution in the states of CA, FL. |
| FDA record | Open on fda.gov |