FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
- Recall number
- Z-0325-2017
- Recalling firm
- Encore Medical, Lp
- Product
- Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
- Status
- Terminated
- Initiated
- 2016-09-19
- Posted
- not on file
- Terminated
- 2017-10-20
- Reason
- It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm sent a recall notification letter to affected consignees on 9/19/16. The field safety notice provided a newly revised Surgical Technique to educate users on proper use of the device.
- Quantity
- 436 units
- Distribution
- US
- Lot, serial or model codes
- 202351L01, 202434L01, 203779L01, 202351L02, 202434L02, 202351L03, 202434L03, 203779L03, 202351L04, 202434L04, 202351L05, 202434L05, 202351L06, 202434L06, 203779L06, 202351L07, 202434L07, 203779L07, 202351L08, 202434L08, 203779L08, 202351L09, 202434L09, 202351L10, 202434L10, 203203L01
- 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