Encore Reverse Shoulder Prosthesis (RSP) System, Standard… recallZ-0185-2008 · Encore Medical, Lp · initiated Aug 8, 2007
Terminated All recalls posted in December 2007
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
Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa.
FDA root cause category: Other
What the company is doing
Encore notified their sales reps (direct accounts) via telephone and overnight letter on 08/08/07. Encore sales reps were asked to return all outstanding devices, for which they would be given replacements. Notification of implanting surgeons was done by phone and letter (Urgent : Device Recall) between 08/07 and 09/12/07. Implanting surgeons notified of recall and asked to closely monitor patients who had received and already been implanted with the affected lots. If explant was required decision of the surgeons, they were asked to notify the recalling firm.
Recall details
- Recall number
- Z-0185-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 8, 2007
- Posted by the FDA
- Dec 19, 2007
- Recalling firm
- Encore Medical, Lp
- Quantity
- 25 units.
- Product code
- KWS
- FDA submissions
- K041066
- Distribution
- Nationwide:Direct accounts and surgeons in the following states: CA, GA, IA, MA, MD, MI, MO, SC, TX and UT.
Product description
Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket Insert; Catalog #: 508-00-040; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 78758.
Code information (models, lots, serial numbers)
Lot #: 601482.
Other devices under the same FDA submission
14 devices cleared under K041066 — 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 506-03-130Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall5 reports
- DJO SURGICAL 508-00-000Encore Medical, L.P. · shoulder prosthesis, reverse configuration21 reports
- DJO SURGICAL 506-00-006Encore Medical, L.P. · shoulder prosthesis, reverse configuration15 reports
- DJO SURGICAL 506-00-008Encore Medical, L.P. · shoulder prosthesis, reverse configuration10 reports
- DJO SURGICAL 507-06-175Encore Medical, L.P. · shoulder prosthesis, reverse configuration6 reports
- DJO SURGICAL 506-03-114Encore Medical, L.P. · shoulder prosthesis, reverse configuration5 reports
- DJO SURGICAL 506-00-007Encore Medical, L.P. · shoulder prosthesis, reverse configuration5 reports
- DJO SURGICAL 506-03-126Encore Medical, L.P. · shoulder prosthesis, reverse configuration4 reports
- DJO SURGICAL 508-00-008Encore Medical, L.P. · shoulder prosthesis, reverse configuration4 reports
- DJO SURGICAL 506-03-118Encore Medical, L.P. · shoulder prosthesis, reverse configuration3 reports
- DJO SURGICAL 508-00-004Encore Medical, L.P. · shoulder prosthesis, reverse configuration3 reports
- DJO SURGICAL 506-03-138Encore Medical, L.P. · shoulder prosthesis, reverse configuration2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 44800).
- Z-0184-2008 · TerminatedEncore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert; Catalog #: 508-00-036; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 7875…
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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