Recall Z-2004-2016 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Musculoskeletal Transplant Foundation, Inc.
Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.
| Date | Jun 16, 2016 (initiated Apr 21, 2016) |
| Status | Terminated |
| Reason | AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. The non-sterile foil pouch may introduce contamination into the sterile field. |
| Root cause | Packaging process control |
| Action | Musculoskeletal Transplant Foundation (MTF) sent an Voluntary Field Action Notification Letter dated April 21, 2016, and via telephone to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were notified of the situation with the product and provided instructions on how to handle the product. Questions can be directed to Customer Service Customer at 1-800-433-6576. |
| Quantity | 114 units |
| Distribution | nationwide |
| FDA record | Open on fda.gov |