In2Bones, SAS: Medical Device Recall in 2021 - (Recall #: Z-1283-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 9, 2021

Date Posted: March 31, 2021

Recall Number: Z-1283-2021

Event ID: 87341

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.

Status: Terminated

Product Quantity: 60 units

Code Information:

Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062

Distribution Pattern:

US Nationwide distribution in the state of TN.

Voluntary or Mandated:

Voluntary: Firm initiated