Encore Reverse Shoulder Prosthesis (RSP), manufactured and… recallZ-1566-05 · Encore Medical, Lp · initiated Jul 28, 2005
Terminated All recalls posted in September 2005
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
Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit.
FDA root cause category: Other
What the company is doing
Recall was initiated by letter to sales agents on 07/28/2005.
Recall details
- Recall number
- Z-1566-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 28, 2005
- Posted by the FDA
- Sep 21, 2005
- Recalling firm
- Encore Medical, Lp
- Quantity
- 93 primary units and 56 revision units
- Product code
- JWH
- FDA submissions
- K041066
Product description
Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758
Code information (models, lots, serial numbers)
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
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
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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