FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
- Recall number
- Z-1139-2017
- Recalling firm
- Encore Medical, Lp
- Product
- Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
- Status
- Terminated
- Initiated
- 2017-01-10
- Posted
- 2017-02-03
- Terminated
- 2017-05-11
- Reason
- The Empowr PS Insert was reported as missing the impaction slot feature.
- Root cause
- Component design/selection
- Action
- DJO Global sent an Urgent Field Safety Notice dated January 10, 2017, to all affected customers. The Field Safety Notice instructs the agents to notify all individuals within their organization or to any organization where the potentially affected product has been transferred. Customers with questions should contact customer service at 1-800-456-8696. For questions regarding this recall call 512-832-9500.
- Quantity
- 24 units
- Distribution
- Nationwide Distribution to CO, NY, and FL
- Lot, serial or model codes
- 035U1000
- 510(k) numbers
- ["K160342"]
- PMA numbers
- not on file
- Product code
- JWH
- 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