FDA Medical Device Recalls (openFDA)
GRAMERCY EXTREMITY ORTHOPEDICS: GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
- Recall number
- Z-1395-2023
- Recalling firm
- GRAMERCY EXTREMITY ORTHOPEDICS
- Product
- GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
- Status
- Open, Classified
- Initiated
- 2023-04-04
- Posted
- 2023-04-17
- Terminated
- not on file
- 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.
- Root cause
- Mixed-up of materials/components
- Action
- On 4/4/23, recall notices were mailed to customers and distributors who were asked to do the following: 1) Quarantine affected kits so they are ready for removal by the firm s sales reps or other contact. 2) If devices were transferred or further distributed, notify customers, or provide a customer list, so the recalling firm can notify these customers directly. 3) Complete and return the response form to msimpson@gramercyortho.com Customers with questions can contact the firm at 855-436-2278, 9AM 5PM, Monday - Friday.
- Quantity
- 24
- Distribution
- US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.
- Lot, serial or model codes
- UDI-DI B471701200010, Serial Number(Expiration Date): 1022000493(10/13/27), 1022000623(10/13/27), 1022000683(10/13/27), 1022000243(10/13/27, 1022000313(10/13/27), 1022000913(10/13/27), 1022001213(10/13/27), 1022000403(10/13/27), 1022000383(10/13/27), 1022000883(10/13/27), 1022000353(10/13/27), 1022000663(10/13/27), 1022000733(10/13/27), 1022000793(10/13/27), 1022000983(10/13/27), 1022000993(10/13/27), 1022000373(10/13/27), 1022001193(10/13/27), 1022000523(10/13/27), 1022000283(10/13/27), 1022000223(10/13/27), 1022000363(10/13/27), 1022000413(10/13/27), 1022000453(10/13/27)
- 510(k) numbers
- ["K200108"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3012478585
- Firm city
- Richardson
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28