nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Sub...
Reason for Recall / Hazard
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
Product Description & Identification
nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc
Affected Products
nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc
Additional Source Details
| Field | Value |
|---|---|
| City | Belgrade |
| State | MT |
| Event id | 98643 |
| Address 1 | 664 Cruiser Ln |
| Address 2 | N/A |
| Code info | Part #: 90-300-251008 UDI-DI 00849777012478 Lot #(s): 385486-RP25-0080 387070-RP25-0081 415971-RP25-0077 436563-RP25-0082 436564-RP25-0079 436565-RP25-0076 444927-RP25-0078 Part #: 90-300-25508 UDI-DI 00849777012492 Lot #(s): 387071-RP25-0083 418098-RP25-0084 436199-RP25-0085 Part #: 90-300-251004 UDI-DI 00849777012461 Lot #(s): 401347-RP25-0070 415871-RP25-0073 415872-RP25-0074 416678-RP25-0072 416679-RP25-0071 418509-RP25-0075 Part #: 90-400-25508 UDI-DI 00849777012539 Lot #(s): 445442-RP25-0128 |
| Postal code | 59714-9719 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 225 |
| Reason for recall | Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260309 |
| Initial firm notification | Letter |
| Center classification date | 20260421 |
Overview
- Recalling FirmXTANT Medical Holdings, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.