Turon Shoulder System Instrumentation, Turon Trial Pegged… recallZ-0800-2011 · Encore Medical, Lp · initiated Nov 5, 2010
Terminated All recalls posted in December 2010
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
Complaints of fracturing were reported for affected trial products.
FDA root cause category: Device Design
What the company is doing
Encore Medical notified consignees by letter on 11/5/2010.
Recall details
- Recall number
- Z-0800-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 5, 2010
- Posted by the FDA
- Dec 22, 2010
- Recalling firm
- Encore Medical, Lp
- Quantity
- 85 units
- Product code
- KWS
- FDA submissions
- K080402
- Distribution
- TX, FL, SC, GA
Product description
Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical
Code information (models, lots, serial numbers)
Part number 804-25-006, 804-25-007, 804-25-008, 804-25-009, 804-25-010
Other devices under the same FDA submission
36 devices cleared under K080402 — 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 520-00-000Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented30 reports
- DJO SURGICAL 520-01-006Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented22 reports
- DJO SURGICAL 520-46-016Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented16 reports
- DJO SURGICAL 520-01-010Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented15 reports
- DJO SURGICAL 520-01-012Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented14 reports
- DJO SURGICAL 520-42-116Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented14 reports
- DJO SURGICAL 520-42-016Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented14 reports
- DJO SURGICAL 520-50-018Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented14 reports
- DJO SURGICAL 520-01-008Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented13 reports
- DJO SURGICAL 520-46-116Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented12 reports
- DJO SURGICAL 520-50-118Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented11 reports
- DJO SURGICAL 520-46-020Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented10 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 57210).
- Z-0798-2011 · TerminatedTuron Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
- Z-0799-2011 · TerminatedTuron Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical
- Z-0801-2011 · TerminatedTuron Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
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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