FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
- Recall number
- Z-0010-2008
- Recalling firm
- Encore Medical, Lp
- Product
- EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
- Status
- Terminated
- Initiated
- 2007-08-09
- Posted
- 2007-10-10
- Terminated
- 2008-03-10
- Reason
- Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.
- Root cause
- Device Design
- Action
- Firm notified consignees regarding recall via letter on 08/09/07. Consignees informed that Encore customer service representatives would be contacting them to exchange recalled units with replacements.
- Quantity
- 5 units.
- Distribution
- Products distributed to direct accounts in CA, FL and MD.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K020741","K022437"]
- PMA numbers
- not on file
- Product code
- HWA
- 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