Z-1498-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- March 26, 2021
- Termination Date
- April 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction. The procedural kits have no kit specific labeling. Each product within the kits has its own product specific labeling.
Reason for Recall
Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used
Distribution Pattern
International distribution in the countries of Canada, Italy.
Code Information
Serial Numbers: 001, 005