EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
A medical device manufacturer is recalling EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthe due to Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, MD
Page updated: Jan 10, 2026