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

Recall Z-0953-2015 — The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impa

U.S. FDA — Device Enforcement · United States · 2014-11-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0953-2015
Date of alert: 2014-11-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: DePuy Orthopaedics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10603295423324

Reported risk: Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in the patient if not observed during surgery.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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