Femoral nail implant recalled for product labeling and packaging mismatch
Smith & Nephew is recalling 32 units of a femoral nail implant due to labeling mismatch. The package contained 40cm implants but was labeled as 36cm, which could result in incorrect surgical implantation.
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 with no reported illnesses or injuries. The mismatch between labeled and actual implant size poses a risk of incorrect surgical implantation, but no patient harm has been documented. Per the rubric, risk-of-harm products without reported injury are scored as High.
Plain-English summary
Smith & Nephew, Inc. is recalling 32 units of TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM orthopedic implants (UDI/DI 03596010500922, Batch Number 21KSM0606) due to a packaging and labeling discrepancy.
The problem: packages labeled as containing 36cm implants were found to contain 40cm implants instead. This mismatch between the label and actual product could result in surgeons using the wrong-sized implant for patients requiring femoral nail fixation, potentially affecting surgical outcomes and patient safety.
The affected batch was distributed to medical facilities in the United States, Canada, Mexico, Panama, the United Arab Emirates, and several European countries including Germany, Spain, the United Kingdom, Poland, and others.
If you received this product, verify the actual implant size against the package label before use. Contact your Smith & Nephew representative if you identify any mismatched inventory. Patients who may have received this implant should contact their orthopedic surgeon for evaluation.
The recalled product
- Product
- TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- mislabeling
- product-misidentification
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 21KSM0606
Distribution
Distributed in 3 states:
- CA
- DE
- PA
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