Z-0798-2011

Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical

Name: Z-0798-2011 Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
Creator: Encore Medical, Lp
Published: 2010-11-05
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2010-11-05 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical on 2010-11-05. The reason FDA records is "Complaints of fracturing were reported for trial products". 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-0798-2011
Status: Terminated
Initiated: 2010-11-05
Posted: 2010-12-22
Terminated: 2011-04-05
Recalling firm: Encore Medical, LP
Product: Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Complaints of fracturing were reported for trial products.
Root cause tag: design
FDA root cause: Device Design
Action: Encore Medical notified consignees by letter on 11/5/2010.
Quantity in commerce: 425 units
Distribution: TX, FL, SC, GA
Product codes and lots: Part numbers: 804-05-021, 804-05-022, 804-05-023, 804-05-024, 804-05-025, 804-05-026, 804-05-027, 804-05-028, 804-05-029, 804-05-030, 804-05-031, 804-05-032, 804-05-033, 804-05-034, 804-05-035, 804-05-036, 804-05-037, 804-05-038, 804-05-039, 804-05-040, 804-05-041, 804-05-042, 804-05-043, 804-05-044, 804-05-045

Product code KWS

K080402Class IIEncore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model 520-38Encore Medical L.P. / cleared 2008-03-28

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)