Z-2004-2016 Class II Terminated
FDA device recall Z-2004-2016 was initiated by Musculoskeletal Transplant Foundation, Inc. on April 21, 2016 and is designated Class II. 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. The recall status is terminated (terminated October 18, 2016). Affected quantity: 114 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 13, 2016
- Initiation Date
- April 21, 2016
- Termination Date
- October 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 114 units
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.
Distribution Pattern
nationwide
Code Information
Serial 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122