3DKNEE Tibial Insert Trial, Size 2, 13mm Right recallZ-1539-2008 · Encore Medical, Lp · initiated Feb 20, 2008
Terminated All recalls posted in August 2008
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
Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side.
FDA root cause category: Error in labeling
What the company is doing
Firm notified consignee by phone and asked them to return any outstanding product on 02/20/08.
Recall details
- Recall number
- Z-1539-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 20, 2008
- Posted by the FDA
- Aug 20, 2008
- Recalling firm
- Encore Medical, Lp
- Quantity
- 6 units.
- Product code
- JWH
- FDA submissions
- K020114
- Distribution
- Distribution --- country of Germany.
Product description
3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability.
Code information (models, lots, serial numbers)
Lot #53906407
Other devices under the same FDA submission
54 devices cleared under K020114 — 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 391-09-610Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- DJO SURGICAL 391-09-608Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- DJO SURGICAL 392-09-606Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- DJO SURGICAL 392-09-608Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- DJO SURGICAL 391-09-606Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- DJO SURGICAL 392-11-606Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- DJO SURGICAL 391-09-604Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- DJO SURGICAL 391-13-604Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- DJO SURGICAL 392-09-604Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- DJO SURGICAL 392-11-610Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- DJO SURGICAL 391-11-608Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- DJO SURGICAL 392-09-610Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 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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