Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Reported: August 18, 2021 Initiated: June 29, 2021 #Z-2250-2021
Product Description
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Reason for Recall
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).
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 29 devices
- Distribution
- US Nationwide Distribution
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.. Recalled by Exactech, Inc.. Units affected: 29 devices.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 18, 2021. Severity: Moderate. Recall number: Z-2250-2021.
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