Reported Jul 27, 2022 · Ongoing
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for 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?
- ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation
- for the femoral implant Part Number254400525
- Lot codes and dates
- GTIN10603295434061
- Lots
AB4536235AB4733296AB4841493AB4810808AB4841495AB4904565AB4967214AB5004557and AB5034303
- Amount recalled
- 872 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain
This product could cause temporary or reversible health problems — stop using it.
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