Class II — GRAMERCY EXTREMITY ORTHOPEDICS
| Recalling firm | Gramercy Extremity Orthopedics, LLC. |
|---|---|
| Registered facility | GRAMERCY EXTREMITY ORTHOPEDICS, LLC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm - 60mm; not the correct drill depth range of 10mm - 40mm. |
| Product | GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System |
| Quantity | 24 |
| Distribution | US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ. |
| Initiated | 2023-04-04 |
| Classified | 2023-04-17 |
| Recall number | Z-1395-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GRAMERCY EXTREMITY ORTHOPEDICS (Z-1395-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92051/
Alerts for Gramercy Extremity Orthopedics, LLC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.