FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant.
Lot Codes / Batch Numbers
All Revision A and Revision B Impactors.
Products Sold
All Revision A and Revision B Impactors.
A medical device manufacturer is recalling FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by due to Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery.
Recommended Action
Per FDA guidance
Recall notification sent via letter starting on 08/04/07. Consignees asked to quarantine and return affected devices. Contact Encore Medical, Lp at 1-512-834-6330 for assistance.
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
FL, TX
Page updated: Jan 10, 2026