FDAFDA · Food and drugs·Recall number Z-2004-2016
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.
Published July 13, 2016 · Recall initiated: April 21, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Musculoskeletal Transplant Foundation, Inc.
- Distributor
- nationwide
- Lot
- Serial 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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