Z-1566-05

Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric...

Name: Z-1566-05 Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric...
Creator: Encore Medical, Lp
Published: 2005-07-28
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2005-07-28 / Terminated

FDA source

Encore Medical, Lp began a recall of Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758 on 2005-07-28. The reason FDA records is "Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1566-05
Status: Terminated
Initiated: 2005-07-28
Posted: 2005-09-21
Terminated: 2007-04-19
Recalling firm: Encore Medical, LP
Product: Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit.
FDA root cause: Other
Action: Recall was initiated by letter to sales agents on 07/28/2005.
Quantity in commerce: 93 primary units and 56 revision units
Product codes and lots: Catalog number: 506-00-006, lot numbers: 260212, 260222, and 244642; Catalog number: 506-00-007, lot number: 250272; Catalog number: 506-00-008, lot numbers: 260242, 254342, 260252, 244662, and 244312; Catalog number: 507-06-175, lot numbers: 261832, 244732, 967721, and 006192; Catalog number: 507-08-175, lot numbers: 261842, 241392, 872681, and 872671

Product code JWH

K041066Class IIEncore Reverse Shoulder ProsthesisEncore Medical L.P. / cleared 2005-03-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)