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.
This recall has been terminated (originally issued October 10, 2007).
- Recall Initiated
- August 9, 2007
- Posted
- October 10, 2007
- Terminated
- March 10, 2008
- Recall Number
- Z-0010-2008
- Quantity
- 5 units.
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.
Distribution
Products distributed to direct accounts in CA, FL and MD.
Lot / Code Info
All lots.
Root Cause
Device Design
Action Taken
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.