FDA Medical Device Recalls (openFDA)
Musculoskeletal Transplant Foundation, Inc.: AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
- Recall number
- Z-1066-2024
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc.
- Product
- AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
- Status
- Open, Classified
- Initiated
- 2023-12-22
- Posted
- 2024-02-09
- Terminated
- not on file
- Reason
- Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 89
- Distribution
- Product was distributed to Minnesota.
- Lot, serial or model codes
- Donor Lot 02921115411127. UDI-DI: W4184227010T0473
- 510(k) numbers
- ["K042125"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3001236616
- Firm city
- Edison
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28