Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Reported: November 11, 2015 Initiated: September 23, 2015 #Z-0201-2016
Product Description
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Reason for Recall
Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 8
- Distribution
- US Distribution to states of: AZ, CO, FL, and MD.
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation. Recalled by Exactech, Inc.. Units affected: 8.
Why was this product recalled? ▼
Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2015. Severity: Moderate. Recall number: Z-0201-2016.
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