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

Recall Z-1319-2015 — DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.

U.S. FDA — Device Enforcement · France · 2015-03-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1319-2015
Date of alert
2015-03-09
Country / jurisdiction
France
Risk level
Class II
Risk type
recall
Brand
In2Bones, SAS
Product category
device
Product type
Devices
Reported risk: Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
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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