Recall Z-1562-2021— Musculoskeletal Transplant Foundation, Inc.
Class II · Terminated
Class II FDA medical device recall by Musculoskeletal Transplant Foundation, Inc., initiated 2021-03-29, terminated 2023-04-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery.
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-29
- Terminated
- 2023-04-27
- Firm location
- Edison, NJ, United States
Product description
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
Reason for recall
3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery
Data sourced from openFDA. This site is unofficial and independent of the FDA.