FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R… recallZ-0418-2012 · Encore Medical, Lp · initiated Aug 17, 2011
Terminated All recalls posted in January 2012
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 sterility has the potential to be compromised.
FDA root cause category: Packaging
What the company is doing
Encore Medical Lp sent a Urgent Field Safety Notice dated August 17, 2011. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately quarantine these devices if you have not already done so. Contact Customer Service to obtain replacement devices as well as an RMA. Return all affected devices by October 31, 2011, using the RMA Customer Service provided in step #3. If you have any further questions you may call (512 ) 834-6330. For International Customer Service please call (512) 834-6275.
Recall details
- Recall number
- Z-0418-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 17, 2011
- Posted by the FDA
- Jan 11, 2012
- Recalling firm
- Encore Medical, Lp
- Quantity
- 169 units
- Product code
- JDI
- FDA submissions
- K961890
- Distribution
- Worldwide Distribution -- USA ( nationwide ) including the states of WI, NY, MO, TX, FL, CA, UT, AZ, Puerto Rico, and the country Japan.
Product description
FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm DJO Surgical 9800 Metric Blvd., Austin, TX 78758 The Foundation Non-Porous Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with bone cement.
Code information (models, lots, serial numbers)
All devices packaged prior to July 1, 2008. Model/Catalog Number: 460-01-090, 460-01-105, 460-01-120, 460-01-135, 460-01-150, 460-01-165
Other devices under the same FDA submission
8 devices cleared under K961890 — 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 450-01-090Encore Medical, L.P. · Prosthesis, Hip, Femoral Component, Cemented, Metal4 reports
- DJO SURGICAL 450-01-105Encore Medical, L.P. · Prosthesis, Hip, Femoral Component, Cemented, Metal3 reports
- DJO SURGICAL 450-01-120Encore Medical, L.P. · Prosthesis, Hip, Femoral Component, Cemented, Metal3 reports
- DJO SURGICAL 450-01-080Encore Medical, L.P. · Prosthesis, Hip, Femoral Component, Cemented, Metal2 reports
- DJO SURGICAL 460-01-105Encore Medical, L.P. · Prosthesis, Hip, Femoral Component, Cemented, Metal2 reports
- DJO SURGICAL 450-01-150Encore Medical, L.P. · Prosthesis, Hip, Femoral Component, Cemented, Metal1 report
- DJO SURGICAL 460-01-120Encore Medical, L.P. · Prosthesis, Hip, Femoral Component, Cemented, Metal1 report
- DJO SURGICAL 460-01-150Encore Medical, L.P. · Prosthesis, Hip, Femoral Component, Cemented, Metal1 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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