Z-2136-2013Class II

SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis...

Name: Z-2136-2013 SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis...
Creator: Stelkast Co
Published: 2013-06-24
License: https://open.fda.gov/license/

Globus Medical, Inc. / initiated 2013-06-24 / Terminated / root cause: manufacturing process

FDA source

Stelkast Co began a recall of SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative... on 2013-06-24. FDA classified it as Class II and gives the reason as "The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw". 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-2136-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-24
Posted: 2013-09-03
Terminated: 2014-10-08
Recalling firm: Globus Medical, Inc.
Product: SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stelkast called and emailed all customers on June 24, 2013, to notify them of the recall. Customers were asked to recover all affected products from their inventory and return them to Stelkast. Customers were instructed to contact Stelkast Customer Service for a Return Authorization (RA) Number prior to shipment to Stelkast. Customers with questions were instructed to call 1-888-273-1583. For questions regarding this recall call 724-941-6368.
Quantity in commerce: 11
Distribution: Nationwide Distribution including TX, VA, OK, and PA
Product codes and lots: Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2136-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2136-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03

Product code JWH

K021908Class IIProven Modular Posterior Stabilized FemoralStelkast Company / cleared 2002-07-09

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)