Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created oss
FDA device recall Z-2004-2016 · posted 2016-06-16 · Terminated
Recall details
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- MBP
- Quantity affected
- 114 units
- Distribution
- nationwide
- Date initiated
- 2016-04-21
- Date posted
- 2016-06-16
- Date terminated
- 2016-10-18
- Location
- Edison, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AFT ALLOGRAFT FILLER TUBE (K060161) | Musculoskeletal Transplant Foundation | 2006-03-21 |
| AFT (K042125) | Musculoskeletal Transplant Foundation | 2005-07-28 |