Reported Jan 21, 2015 · Terminated
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces
- with several related ATTUNE instrumentskeel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impactor, for the purpose of impaction, extraction, and insertion applications at steps within the surgical procedure. Due to the frequency of its use, two impaction handles are supplied in each kit
- Lot codes and dates
- CATALOG NO. : 2544-01-017
- LOT NUMBERAll
- Lots Barcode GTIN10603295423324
- Amount recalled
- 7,944
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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