FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: 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.
- Recall number
- Z-0418-2012
- Recalling firm
- Encore Medical, Lp
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-08-17
- Posted
- 2012-01-11
- Terminated
- 2012-05-11
- Reason
- The sterility has the potential to be compromised.
- Root cause
- Packaging
- Action
- 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.
- Quantity
- 169 units
- Distribution
- Worldwide Distribution -- USA ( nationwide ) including the states of WI, NY, MO, TX, FL, CA, UT, AZ, Puerto Rico, and the country Japan.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K961890"]
- PMA numbers
- not on file
- Product code
- JDI
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28