Orthopedic Surgical Guide with Defective Spring Subject to Corrosion
DePuy Orthopaedics is recalling 872 units of the ATTUNE Measured Sizing and Rotation Guide due to a manufacturing defect. A galvanized steel spring was used instead of stainless steel, which may cause corrosion and surgical complications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical instrument with potential for serious patient harm, including bone loss and joint mechanics failure. No reported injuries or complications are documented in the recall notice, so the severity reflects risk of harm rather than confirmed injury.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 872 units of the ATTUNE Measured Sizing and Rotation Guide (Part Number 254400525). This surgical instrument is used to size the femur and align the bone cuts in knee replacement procedures.
The recalled units were manufactured with a galvanized high-carbon steel spring instead of the correct 302 stainless steel spring. This material substitution creates a risk of oxidation and corrosion within the device.
Corrosion of the spring may result in debris in the surgical field and surgical delay. Post-operatively, patients may develop bone loss (osteolysis), poor joint mechanics, soft tissue irritation, and pain.
The recalled units were distributed nationwide and internationally. Lot numbers affected include AB4536235, AB4733296, AB4841493, AB4810808, AB4841495, AB4904565, AB4967214, AB5004557, and AB5034303.
The recalled product
- Product
- 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
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- spring-corrosion
- osteolysis
- surgical-debris
- surgical-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- GTIN: 10603295434061 Lots: AB4536235
- AB4733296
- AB4841493
- AB4810808
- AB4841495
- AB4904565
- AB4967214
- AB5004557
- and AB5034303
Distribution
Distributed nationwide across the United States.
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