FDA recall Z-0813-2018

Product

Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.

Reason for recall

Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.

Distribution

Worldwide Distribution - USA Distribution

Key facts

Status

Terminated

Initiation date

2017-10-23

Report date

2018-03-07

Termination date

2019-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wall Township, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0813-2018