Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1283-2021 — In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.

U.S. FDA — Device Enforcement · France · 2021-02-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1283-2021
Date of alert
2021-02-09
Country / jurisdiction
France
Risk level
Class II
Risk type
recall
Brand
In2Bones, SAS
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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