FDA recall Z-1562-2021

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

Reason for recall

3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery

Distribution

US Nationwide distribution in the state of MN.

Key facts

Status

Terminated

Initiation date

2021-03-29

Report date

2021-05-19

Termination date

2023-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Edison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1562-2021