Z-1238-2013Class II

Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis...

Name: Z-1238-2013 Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis...
Creator: Synthes USA HQ, Inc.
Published: 2013-02-22
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-02-22 / Terminated / root cause: design

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of... on 2013-02-22. FDA classified it as Class II and gives the reason as "The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1238-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-22
Posted: 2013-05-03
Terminated: 2015-08-31
Recalling firm: Synthes GmbH
Product: Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly.
Product code: KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Reason for recall: The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events.
Root cause tag: design
FDA root cause: Device Design
Action: Synthes sent an Urgent Notice: Medical Device Recall letter dated February 22, 2013, to all affected consignees. The letter requested consignees examine their inventory, remove them from use and return them to Synthes. Customers were asked to complete the attached Verification Section at the end of the letter indicating whether or not they have any of the affected product. For questions customers were instructed to call 610-719-5450 or email [email protected]. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 417
Distribution: Nationwide Distribution: USA including states of: IL, IN, MA, MI, MO, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WI.
Product codes and lots: All Lots of Part Numbers: 03.402.018, 03.402.020, 03.402.022, 03.402.024, 03.402.026, 03.402.028, 03.402.218, 03.402.220, 03.402.222, 03.402.224, 03.402.226, 03.402.228, 03.402.418, 03.402.420, 03.402.422, 03.402.424, 03.402.426, 03.402.428, 03.402.618, 03.402.620, 03.402.622, 03.402.624, 03.402.626, and 03.402.628.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1238-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1238-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03

Product code KWI

K112030Class IISynthes Radial Head Prosthesis SystemSynthes USA, LLC / cleared 2012-06-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)