Device product
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
Z-1562-2021
Product summary
- Event
- Event 87677
- Status
- Terminated
- Classification
- Class II
- Quantity
- 672 units
- Official record key
device-enforcement:Z-1562-2021
Official wording
Reason: 3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery
Code information: Lot/Serial Numbers: 03818070421114 00319018541145 00319022171149 00419019631149 09819009071105 09819036171142
Distribution pattern: US Nationwide distribution in the state of MN.
Derived failure modes
-
Unknown
3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery