3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right… recallZ-1433-2010 · Encore Medical, Lp · initiated Mar 19, 2010
Terminated All recalls posted in April 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
Affected product had incorrect color label which is a secondary visual indicator for sizing.
FDA root cause category: Packaging process control
What the company is doing
Encore Medical, LP notified consignees by e-mail dated March 19, 2010. Consignees were requested to return the affected product to the firm. For further information, contact Encore Medical, LP at 1-888-838-3668.
Recall details
- Recall number
- Z-1433-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 19, 2010
- Posted by the FDA
- Apr 26, 2010
- Recalling firm
- Encore Medical, Lp
- Quantity
- 7 units
- Product code
- JWH
- FDA submissions
- K020114
- Distribution
- Worldwide Distribution -- United States (UT, IA) and Germany.
Product description
3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee pain and restoring knee joint function.
Code information (models, lots, serial numbers)
Catalog Number: 392-11-604, Lot Number: 59600085.
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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