EPIK KNEE SYSTEM Angled Insert Impactor RM/LL recallZ-0010-2008 · Encore Medical, Lp · initiated Aug 9, 2007
Terminated All recalls posted in October 2007
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
Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.
FDA root cause category: Device Design
What the company is doing
Firm notified consignees regarding recall via letter on 08/09/07. Consignees informed that Encore customer service representatives would be contacting them to exchange recalled units with replacements.
Recall details
- Recall number
- Z-0010-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 9, 2007
- Posted by the FDA
- Oct 10, 2007
- Recalling firm
- Encore Medical, Lp
- Quantity
- 5 units.
- Product code
- HWA
- FDA submissions
- K020741, K022437
- Distribution
- Products distributed to direct accounts in CA, FL and MD.
Product description
EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Code information (models, lots, serial numbers)
All lots.
Other devices under the same FDA submission
17 devices cleared under K020741, K022437 — 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 340-40-009Encore Medical, L.P. · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer5 reports
- DJO SURGICAL 340-45-009Encore Medical, L.P. · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer5 reports
- DJO SURGICAL 340-37-009Encore Medical, L.P. · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer3 reports
- DJO SURGICAL 340-42-009Encore Medical, L.P. · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer3 reports
- DJO SURGICAL 300-01-035Encore Medical, L.P. · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2 reports
- DJO SURGICAL 300-01-045Encore Medical, L.P. · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2 reports
- DJO SURGICAL 300-02-045Encore Medical, L.P. · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2 reports
- DJO SURGICAL 340-45-010Encore Medical, L.P. · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2 reports
- DJO SURGICAL 200-01-108Encore Medical, L.P. · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- DJO SURGICAL 200-01-110Encore Medical, L.P. · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- DJO SURGICAL 200-02-110Encore Medical, L.P. · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- DJO SURGICAL 300-02-035Encore Medical, L.P. · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 38951).
- Z-0009-2008 · TerminatedEPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
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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