Reported Jan 14, 2015 · Terminated
Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized…
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?
- Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact
- and drive home its relevant mating part
Fixed Tibial bearing(254401003) Rotating Tibial Platform(254401004) and Femoral impactor(254401006)
- Lot codes and dates
- CATALOG NO. : ATTUNE INTUITION Impactors Rotating Tibial Platform, (254401004)
- Barcode GTIN NumberRotating Tibial Platform, ......... 10603295130208 ALL LOTS
- Amount recalled
- 3861
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
This product could cause temporary or reversible health problems — stop using it.
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