FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
- Recall number
- Z-0165-2016
- Recalling firm
- Encore Medical, Lp
- Product
- Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
- Status
- Terminated
- Initiated
- 2015-09-16
- Posted
- 2015-10-26
- Terminated
- 2016-01-04
- Reason
- The labeling is missing the size/diameter information.
- Root cause
- Labeling design
- Action
- DJO Surgical sent an Urgent Field Safety Notice dated September 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested the consignees complete and return a response card and return affected devices for replacement. For further questions call (512) 832-6302.
- Quantity
- 209 units
- Distribution
- US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.
- Lot, serial or model codes
- 471T1-001/011; 472T1-000/014; 473T1-000/015; 474T1-000/010; 475T1-000/008
- 510(k) numbers
- K140830
- PMA numbers
- not on file
- Product code
- OIY
- 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