ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling 872 units of the ATTUNE Measured Sizing and Rotation Guide (Part Number 254400525) due to a manufacturing defect. The device was manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless Steel spring. This incorrect material has the potential to oxidize and corrode during use, which could result in surgical delay, debris in the surgical field, bone loss (osteolysis), poor joint mechanics, soft tissue irritation, and pain.
The recalled devices were distributed nationwide and internationally to countries including Canada, Mexico, Australia, Japan, Germany, France, the United Kingdom, and many others. The affected lot numbers are AB4536235, AB4733296, AB4841493, AB4810808, AB4841495, AB4904565, AB4967214, AB5004557, and AB5034303. The source document does not specify what actions affected consumers or healthcare providers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Kore Quantity: 872 units Lot/code info: GTIN: 10603295434061 Lots: AB4536235, AB4733296, AB4841493, AB4810808, AB4841495, AB4904565, AB4967214, AB5004557, and AB5034303
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.