Z-0970-2015Class II

EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a...

Name: Z-0970-2015 EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a...
Creator: Stelkast Co
Published: 2014-12-01
License: https://open.fda.gov/license/

Globus Medical, Inc. / initiated 2014-12-01 / Terminated / root cause: manufacturing process

FDA source

Stelkast Co began a recall of EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis... on 2014-12-01. FDA classified it as Class II and gives the reason as "Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0970-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-01
Posted: 2015-01-14
Terminated: 2015-05-06
Recalling firm: Globus Medical, Inc.
Product: EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On December 1, 2014, phone calls were made to all direct accounts to notify them of the recall and to request immediate recovery and return of the SC3425 EXp PS Tibial Tray Inserts and SC3453 EXp CR-HF Inserts from their inventory.
Quantity in commerce: 553
Distribution: TX, MD, IN, KS, CA, PA, GA, WA, NY, IL.
Product codes and lots: part numbers SC3425 and SC3453, with lot numbers:28592-103112 28593-102412 28602-110112 28603-110112 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31031-121013 31033-121013 31040-121013 31249-022514 31261-020414 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31029-120913 31040-121013 31043-120913 31243-022414 31244-022414 31249-022514 31252-021314 31255-020414 31261-020414 32083-080714 31028-120913 31031-121013 31032-121013 31033-121013 31042-121013 31044-120913 31243-022414 31244-022414 31245-022414 31252-021314 31255-020414 31261-020414 31263-021314 31264-031114 31265-031114 31266-031114 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31029-120913 31034-120913 31040-121013 31043-120913 31044-120913 31249-022514 31255-020414 32083-080714 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31028-120913 31029-120913 31031-121013 31032-121013 31033-121013 31034-120913 31037-121013 31040-121013 31042-121013 31044-120913 31243-022414 31244-022414 31245-022414 31249-022514 31252-021314 31255-020414 31261-020414 31263-021314 31265-031114 32081-080714 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28613-110112 28622-112812 28623-112812 28624-112812 31034-120913 28599-111412 28617-110112 31028-120913 31032-121013 31042-121013 31044-120913 31243-022414 31244-022414 31245-022414 31249-022514 31251-022514 31252-021314 31255-020414 31261-020414 31263-021314 31264-031114 31265-031114 31266-031114 28618-110112 28592-103112 28598-103112 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0970-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0970-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-14

Product code JWH

K122883Class IIExp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company / cleared 2013-08-05

MDM coverage of this record lists here, newest first.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)