Femur nail surgical implant mislabeled with incorrect product length
Smith & Nephew recalled a femur nail surgical implant because some packages contained a 40cm product instead of the labeled 36cm version. No injuries have been reported.
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 a Class II FDA recall of a surgical implant with incorrect product shipped in certain packages. While no illnesses or injuries have been reported, a femur nail of incorrect length (40cm instead of 36cm) represents a risk-of-harm product that could affect surgical outcomes and patient safety.
Plain-English summary
Smith & Nephew, Inc. is recalling the TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT femur surgical implant. The recall was initiated after a complaint indicated that certain packages contained a 40cm version of this product instead of the labeled 36cm version.
A mismatch between the labeled product specifications and the actual product shipped could result in the wrong implant size being used during surgical procedures. This could affect surgical outcomes and proper implant fit.
Thirty units of the affected product (Batch Number 21KSM0598, UDI/DI 03596010500922) have been distributed to healthcare providers in the United States, United Arab Emirates, Canada, Germany, Spain, United Kingdom, Mexico, Panama, and Poland. Healthcare providers should verify that the physical product matches the label before use and contact the manufacturer with any questions or concerns.
The recalled product
- Product
- TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- product-mismatch
- mis-labeling
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 (2)
- UDI/DI 03596010500922
- Batch Number 21KSM0598
Distribution
Distributed in 3 states:
- CA
- DE
- PA
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