Richardson, TX, United States
GRAMERCY EXTREMITY ORTHOPEDICS recalls
1 recall recorded since 2018, most recently on 4 April 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 4 April 2023
- 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.
- Distribution
- US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1395-2023
- GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.