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.
Check against the official notice below — it lists the full affected range.
Musculoskeletal Transplant Foundation, Inc. is recalling 114 units of AFT Diverted Tubes (3/4/Filled) nationwide. These devices are used to treat surgically-created bone defects. The recall was initiated due to a customer complaint involving one unit that had an unsealed Tyvek pouch, which could allow non-sterile contamination to enter the sterile field. All affected units share serial number 04314046801122.
The source document does not specify a remedy or recommended action for consumers who may have received this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: nationwide Quantity: 114 units Lot/code info: Serial 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.