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Terminated

AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007

FDA Recall Z-1562-2021 · Posted None

Recalling FirmMusculoskeletal Transplant Foundation, Inc.
Recall StatusTerminated
Product CodeMQV
Date Initiated2021-03-29
Date Terminated2023-04-27
Product Quantity672 units

Reason for Recall

3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery

Firm Action

Musculoskeletal Transplant Foundation (MTF) issued Voluntary Field Action Notification Letter via FedX on March 29, 2021 to the Distributor. Letter states reason for recall, health risk and action to take: As the distributor. Spineology. we will need you to complete notification to your customers and provide the distribution records. questions. Please feel free to contact me at 732-661-2209. or email MTF RegulatoryAffairs at [email protected]

Root Cause

Packaging change control

Distribution Pattern

US Nationwide distribution in the state of MN.

Official Source

View FDA Recall →

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

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