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.
Recall
- Recall Number
- Z-2004-2016
- Event Number
- 74263
- Firm
- Musculoskeletal Transplant Foundation, Inc.
- FEI Number
- 3001236616
- Product Code
- MBP
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- April 21, 2016
- Posted
- June 16, 2016
- Terminated
- October 18, 2016
- Address
- 125 May St, Ste 300, Edison, NJ, 08837-3264
Description
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.
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.
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.
nationwide
114 units