AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
FDA device recall Z-1067-2024 · posted 2024-02-09 · Open, Classified
Recall details
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc.
- Reason for recall
- Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
- Action taken
- The firm notified their distributor of the issue during a meeting on December 22, 2023. A notification letter was also issued to the distributor. If the device/tissue was transplanted, no further action is warranted. However, if the device/tissue is still available in the customer's inventory, the unit shall be returned to Spineology, the distributor. Should you have any questions, please contact the firm at 732-661-2209, or email MTF Regulatory Affairs at Regulatory_Customer_Inquiry@mtf.org.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- MQV
- Quantity affected
- 50
- Distribution
- Product was distributed to Minnesota.
- Date initiated
- 2023-12-22
- Date posted
- 2024-02-09
- Location
- Edison, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AFT (K042125) | Musculoskeletal Transplant Foundation | 2005-07-28 |