Exactech BIOLOX Delta Femoral Head Hip Prosthesis Recalled for Device Marking Mismatch
Exactech is recalling 29 BIOLOX delta femoral head hip prosthesis components due to a discrepancy between the product label and actual device marking. The mismatch could affect proper device identification and surgical placement.
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 medical device recall involving a risk-of-harm situation where the actual device marking does not match its labeling. No injuries or hospitalizations have been reported, but the marking discrepancy on a surgical implant could affect proper device identification and implantation decisions.
Plain-English summary
Exactech, Inc. is recalling 29 BIOLOX delta femoral head hip prosthesis components due to a discrepancy between the product's packaging/labeling and the actual device marking. The devices were labeled as REF 170-36-00 (36mm +0), but the actual devices were marked as 170-36-03 (36mm +3.5).
This marking discrepancy may result in confusion regarding the actual specifications of the implanted device. Surgeons rely on accurate device identification and specifications for proper implantation technique and patient care decisions.
The affected devices have serial numbers 6465589-6465618 and 6465641, and were distributed nationwide in the United States. Healthcare providers and patients who may have these devices should contact Exactech for further guidance on device identification and any necessary clinical follow-up.
The recalled product
- Product
- Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
- Manufacturer
- Exactech, Inc.
- Hazard
- device-marking-error
- labeling-mismatch
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: 6465589-6465618
- 6465641
Distribution
Distributed nationwide across the United States.
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