NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
Reported: July 30, 2014 Initiated: March 7, 2014 #Z-2086-2014
Product Description
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
Reason for Recall
The femoral stem is lacking specified plasma coating.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 10
- Distribution
- Worldwide Distribution including Spain, Greece and Japan
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.. Recalled by Exactech, Inc.. Units affected: 10.
Why was this product recalled? ▼
The femoral stem is lacking specified plasma coating.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 30, 2014. Severity: Moderate. Recall number: Z-2086-2014.
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