Exactech BIOLOX delta Femoral Head recall
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Why was Exactech BIOLOX delta Femoral Head recalled?
Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 6465589-6465618; 6465641
- Product
- Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
- Recalling firm
- Exactech, Inc.
- Quantity
- 29 devices
- Distribution
- US Nationwide Distribution
- Recall date
- August 18, 2021
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)