[Recalled] 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, an
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | 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. |
|---|---|
| Brand / manufacturer | Musculoskeletal Transplant Foundation, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2004-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 April 2016 |
| EAN / barcode | 04314046801122 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Musculoskeletal Transplant Foundation, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.