Exactech hip prosthesis femoral head labeling and marking discrepancy
Exactech BIOLOX delta Femoral Head prosthesis components were labeled as one size but marked as a different size. This labeling discrepancy could result in implantation of the incorrect component.
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 risk-of-harm medical device with a labeling and marking discrepancy that could result in implantation of an unintended prosthesis component size during surgery. Although no illnesses or injuries have been reported, the hazard warrants a High severity rating per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Exactech, Inc. has recalled 30 Exactech BIOLOX delta Femoral Head hip prosthesis components due to a labeling and marking discrepancy. The devices were packaged and labeled as REF 170-36-00 (36mm +0), but the devices themselves were marked as REF 170-36-03 (36mm +3.5mm).
The mismatch between the label and the actual device marking could lead to implantation of an unintended component size during hip replacement surgery. Patients who have received this product should contact their surgeon or healthcare provider to verify which component was implanted.
The recalled devices have serial numbers 6465619-6465640 and 6465642-6465648 and were distributed nationwide in the United States.
The recalled product
- Product
- Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
- Manufacturer
- Exactech, Inc.
- Hazard
- labeling-discrepancy
- surgical-error-risk
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)
- Serial Numbers: 6465619-6465640
- 6465642-6465648
Distribution
Distributed nationwide across the United States.
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