FDA recall Z-1283-2021

Product

In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.

Reason for recall

This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use.

Distribution

US Nationwide distribution in the state of TN.

Key facts

Status

Terminated

Initiation date

2021-02-09

Report date

2021-03-31

Termination date

2024-07-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ecully, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1283-2021