Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1283-2021 · Posted None

Recalling FirmIn2Bones, SAS
Recall StatusTerminated
Product CodeGFF
Date Initiated2021-02-09
Date Terminated2024-07-11
Product Quantity60 units

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.

Firm Action

A "FIELD CORRECTIVE ACTION MEDICAL DEVICE BATCH RECALL" and reply form dated 02/09/2021 were sent to customers.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the state of TN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑