CLASS II Device recall · Reported 30 Jul 2014 · FDA Enforcement Report
Novation Femoral Stem, Tapered Extended offset recalled by Exactech
Exactech is recalling Novation Femoral Stem, Tapered Extended offset, plasma- coated, press fit. The recall was initiated on 7 Mar 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2086-2014
- FDA event ID
- 68341
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Mar 2014
- FDA classified
- 21 Jul 2014
- Reported
- 30 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 7 Mar 2014 | Recall initiated by company | |
| 21 Jul 2014 | Classified by FDA | +136 days |
| 30 Jul 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The femoral stem is lacking specified plasma coating.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution including Spain, Greece and Japan
Questions about this recall
Why was it recalled?
The femoral stem is lacking specified plasma coating.
Which lots are affected?
Serial Numbers: 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, and 2910252
Where was it sold?
Worldwide Distribution including Spain, Greece and Japan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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