Z-2739-2011

Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R...

Name: Z-2739-2011 Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R...
Creator: Encore Medical, Lp
Published: 2011-04-18
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2011-04-18 / Terminated / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The... on 2011-04-18. The reason FDA records is "The device has the potential to not appropriately mate with the humeral stem". 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-2739-2011
Status: Terminated
Initiated: 2011-04-18
Posted: 2011-07-06
Terminated: 2012-01-25
Recalling firm: Encore Medical, LP
Product: Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prosthesis (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant (s), and a functional deltoid muscles in necessary to use the device.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: The device has the potential to not appropriately mate with the humeral stem.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DJO Surgical sent an "URGENT FIELD SAFETY NOTICE" letter dated April 18, 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructed customers to quarantine affected products and to contact Customer Service to obtain replacement products and a RMA. Questions are directed to the Director of Commercial Logistics at 512-834-6330.
Quantity in commerce: 81 units
Distribution: Worldwide Distribution--USA (nationwide) including the states of CA, FL, IL, LA, MA, MD, ME, NM, NY, OK, PA, SC, TN, TX, UT, and WA and the countries of Germany, Italy, and United Kingdom.
Product codes and lots: Model Number 508-00-000: lot #s: 848C1078, 848C1079, 848C1080, 848C1081, 848C1082, 848C1083, 848C1084, 848C1085, 848C1086, 848C1087 Model number: 508-00-008, lot #'s: 854C1016

Product code KWS

K051075Class IIEncore Reverse Shoulder ProsthesisEncore Medical L.P. / cleared 2005-05-27

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)