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Open, Classified

AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)

FDA Recall Z-1067-2024 · Posted 2024-02-09

Recalling FirmMusculoskeletal Transplant Foundation, Inc.
Recall StatusOpen, Classified
Product CodeMQV
Date Initiated2023-12-22
Product Quantity50

Reason for Recall

Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.

Firm 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 [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

Product was distributed to Minnesota.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042125AFTMusculoskeletal Transplant Foundation · 2005-07-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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