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.
Reported: July 13, 2016 Initiated: April 21, 2016 #Z-2004-2016
Product 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.
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.
Details
- Recalling Firm
- Musculoskeletal Transplant Foundation, Inc.
- Units Affected
- 114 units
- Distribution
- nationwide
- Location
- Edison, NJ
Frequently Asked Questions
What product was 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, and spine. Product Code: 227005.. Recalled by Musculoskeletal Transplant Foundation, Inc.. Units affected: 114 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 13, 2016. Severity: Moderate. Recall number: Z-2004-2016.
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