Reverse Shoulder Prosthesis System RSP Humeral Socket… recallZ-2739-2011 · Encore Medical, Lp · initiated Apr 18, 2011
Terminated All recalls posted in July 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Encore Medical, Lp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The device has the potential to not appropriately mate with the humeral stem.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2739-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 18, 2011
- Posted by the FDA
- Jul 6, 2011
- Recalling firm
- Encore Medical, Lp
- Quantity
- 81 units
- Product code
- KWS
- FDA submissions
- K051075
- 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 description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
28 devices cleared under K051075 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
- DJO SURGICAL 509-01-436Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall62 reports
- DJO SURGICAL 508-40-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration111 reports
- DJO SURGICAL 509-01-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall52 reports
- DJO SURGICAL 508-01-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall40 reports
- DJO SURGICAL 509-01-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration79 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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