FDA Enforcement
Class II
Terminated
AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007
Recall: Z-1562-2021
·
Reported May 19, 2021
Enforcement
- Recall Number
- Z-1562-2021
- Event ID
- 87677
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Musculoskeletal Transplant Foundation, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 19, 2021
- Initiation Date
- March 29, 2021
- Classification Date
- May 12, 2021
- Termination Date
- April 27, 2023
- Address
- 125 May St Ste 300, Edison, NJ, 08837-3264, United States
Description
AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007
Reason
3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery
Code Info
Lot/Serial Numbers: 03818070421114 00319018541145 00319022171149 00419019631149 09819009071105 09819036171142
Distribution
US Nationwide distribution in the state of MN.
Quantity
672 units