CLASS II Device recall · Reported 4 Nov 2020 · FDA Enforcement Report
Equinoxe Platform Fracture Stem, Right recalled by Exactech
Exactech is recalling Equinoxe Platform Fracture Stem, Right, distributed nationwide in the US. The recall was initiated on 25 Sep 2020 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-0308-2021
- FDA event ID
- 86590
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Sep 2020
- FDA classified
- 29 Oct 2020
- Reported
- 4 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Sep 2020 | Recall initiated by company | |
| 29 Oct 2020 | Classified by FDA | +34 days |
| 4 Nov 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Product as listed by the FDA
Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.
Nationwide CaliforniaColoradoFloridaIndianaKentuckyNew YorkOhioPuerto RicoTexas
Questions about this recall
Is Equinoxe Platform Fracture Stem, Right recalled?
Yes. Exactech recalled Equinoxe Platform Fracture Stem, Right on 25 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0308-2021.
Why was it recalled?
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Which lots are affected?
Catalog: 304-22-07; Serial Range: 4971292-4971303
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.
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 21 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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