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.
FDA Recall Z-1238-2013 · Posted 2013-05-03
Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeKWI
Date Initiated2013-02-22
Date Terminated2015-08-31
Product Quantity417
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution: USA including states of: IL, IN, MA, MI, MO, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.