NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replac...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2086-2014.
The femoral stem is lacking specified plasma coating.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2086-2014.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Exactech, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2086-2014.
Exactech, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Exactech, Inc. Recall FAQ
Exactech, Inc. is the subject of a medical implants safety report: NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replac.... The notice was published on March 7, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 10 units are potentially affected.