CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report
Plate System, Midfoot/Flatfoot Insert, Part recalled by Epic Extremity
Epic Extremity is recalling Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended, distributed in Florida, Pennsylvania, Virginia. The recall was initiated on 20 Mar 2018 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-1874-2018
- FDA event ID
- 79824
- Recalling firm
- Epic Extremity, Cranberry Twp, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Mar 2018
- FDA classified
- 15 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Mar 2018 | Recall initiated by company | |
| 15 May 2018 | Classified by FDA | +56 days |
| 23 May 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is an error in the caddy artwork that misidentifies a specific plate and screw.
Product as listed by the FDA
Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
Where it was distributed
The products were distributed to the following US states: FL, PA, and VA.
Questions about this recall
Is Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate recalled?
Yes. Epic Extremity recalled Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate on 20 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1874-2018.
Why was it recalled?
There is an error in the caddy artwork that misidentifies a specific plate and screw.
Which lots are affected?
Catalog Number: 2111-0005 Lot: 51464
Where was it sold?
The products were distributed to the following US states: FL, PA, and VA.
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.
More recalls from Epic Extremity
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plate System, Plate Caddy, Part 2111 recalled by Epic Extremity | Epic Extremity | Other | FL, PA, VA |
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