Size 8 right 3DKnee Non-porous Baseplates (Catalog… recallZ-0332-06 · Encore Medical, Lp · initiated Nov 3, 2005
Terminated All recalls posted in December 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
The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
FDA root cause category: Other
What the company is doing
Firm initiated recall on 11/03/05 via letter to all consignees.
Recall details
- Recall number
- Z-0332-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 3, 2005
- Posted by the FDA
- Dec 29, 2005
- Recalling firm
- Encore Medical, Lp
- Quantity
- 14 units.
- Product code
- JWH
- FDA submissions
- K020114
- Distribution
- Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany.
Product description
Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement.
Code information (models, lots, serial numbers)
Lot #434322.
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
Other products in the same recall event
The FDA groups related products into one recall event (event 33991).
- Z-0331-06 · TerminatedSize 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.
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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