Foundation Knee System, Patella Trial, 26 mm, part number… recallZ-1255-2010 · Encore Medical, Lp · initiated Feb 22, 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
One lot of product was incorrectly manufactured. Pegs are larger than specification.
FDA root cause category: Process control
What the company is doing
Firm notified consignees by e-mail on 2/22/2010.
Recall details
- Recall number
- Z-1255-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 22, 2010
- Posted by the FDA
- Apr 7, 2010
- Recalling firm
- Encore Medical, Lp
- Quantity
- 2 units
- Product code
- JWH
- FDA submissions
- K932246
- Distribution
- United States (FL and ID).
Product description
Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551
Code information (models, lots, serial numbers)
Part Number 802-01-019 Lot 53944551
Other devices under the same FDA submission
4 devices cleared under K932246 — 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 110-02-032Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- DJO SURGICAL 110-02-026Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- DJO SURGICAL 110-02-029Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- DJO SURGICAL 110-02-035Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
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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