Recall Z-1718-2025 ยท MQV Filler, Bone Void, Calcium Compound
SCIENCE & BIO MATERIALS
Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
| Date | May 2, 2025 (initiated Apr 7, 2025) |
| Status | Open, Classified |
| Reason | Vials of implant bone granules may contain less product then specified on labeling. |
| Root cause | Process control |
| Action | On April 7, 2025 Science for Biomaterials issued a "Urgent Medical Device Recall" Notification via E-Mail. 1. Verify the presence of Lot 240781 in stock and its distribution, if applicable. 2. Destroy the product after taking photos of the vials contents for exchange. Send us a certificate of destruction. or return to DMs to us for exchange 3. Acknowledge receipt of this batch recall by returning the Response Form to regine.estaun@sbm-fr.com within 7 days of the date of receipt. . |
| Quantity | 30 vials |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021963 | BIOSORB RESORBABLE VOID FILLER Sciences ET Bio Materiaux (Sbm), Jan 28, 2003 |