Epic Extremity Plate System Recalled for Packaging Labeling Error
Epic Extremity, LLC is recalling 6 units of the Epic Extremity Plate System due to a packaging error that misidentifies a specific plate and screw.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a packaging-only problem (caddy artwork error) with no reported injuries or illnesses, which aligns with the 'Low' severity criteria for cosmetic or documentation issues.
Plain-English summary
Epic Extremity, LLC is recalling 6 units of the Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002). The recall is due to an error in the caddy artwork that misidentifies a specific plate and screw.
The affected products were distributed to Florida, Pennsylvania, and Virginia. The specific catalog number is 2111-0005 and the lot number is 51464.
Consumers who have these specific units should contact Epic Extremity, LLC for instructions on how to return the product.
The recalled product
- Product
- Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
- Manufacturer
- Epic Extremity, LLC
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 2111-0005 Lot: 51464
Distribution
Part of a larger recall action
This product is one of 2 recalled by Epic Extremity, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Epic Extremity, LLC
See all →- LowEpic Extremity Plate System Caddy Recalled for Artwork Error
FDA (Devices) · 2018-05-23
Same hazard · mis labeling
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