Z-1395-2023Class II

GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating...

Name: Z-1395-2023 GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating...
Creator: Gramercy Extremity Orthopedics
Published: 2023-04-04
License: https://open.fda.gov/license/

Gramercy Extremity Orthopedics, LLC. / initiated 2023-04-04 / Open, Classified

FDA source

GRAMERCY EXTREMITY ORTHOPEDICS began a recall of GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System on 2023-04-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1395-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-04
Posted: 2023-04-17
Recalling firm: Gramercy Extremity Orthopedics, LLC.
Product: GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Product code: HRS Plate, Fixation, Bone
Reason for recall: 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.
FDA 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 [email protected] Customers with questions can contact the firm at 855-436-2278, 9AM 5PM, Monday - Friday.
Quantity in commerce: 24
Distribution: US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1395-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1395-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-17

Product code HRS

K200108Class IIGEO 1st MTP Joint Arthrodesis Plating SystemGramercy Extremity Orthopedics, LLC / cleared 2020-03-26

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)