Z-1251-2007

Reverse Shoulder Prosthesis (RSP) custom device component; 36mm Glenoid Head, Hooded; Custom device...

Name: Z-1251-2007 Reverse Shoulder Prosthesis (RSP) custom device component; 36mm Glenoid Head, Hooded; Custom device...
Creator: Encore Medical, Lp
Published: 2007-03-22
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2007-03-22 / Terminated / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of Reverse Shoulder Prosthesis (RSP) custom device component; 36mm Glenoid Head, Hooded; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758 on 2007-03-22. The reason FDA records is "Marketed without approval: Investigational devices were implanted during an IDE study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the IDE...". 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-1251-2007
Status: Terminated
Initiated: 2007-03-22
Posted: 2007-09-25
Terminated: 2008-03-27
Recalling firm: Encore Medical, LP
Product: Reverse Shoulder Prosthesis (RSP) custom device component; 36mm Glenoid Head, Hooded; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Marketed without approval: Investigational devices were implanted during an IDE study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the IDE study; and devices implanted as "custom devices" by the manufacturer did not meet the definition of "custom devices" and were, therefore, unapproved devices.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Letters were sent via Certified Mail on 03/22/07 to the surgeons and their associated IRBs. Each letter included a list of the patients to be notified and a form letter that the surgeons could use to notify the patients. Surgeons asked to notify their patients and to provide Encore with documented evidence that patience were notified.
Quantity in commerce: 20 units.
Distribution: Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.
Product codes and lots: 0700-036.

Product code KWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)