Device product
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
Z-0650-2021
Product summary
- Event
- Event 86746
- Status
- Terminated
- Classification
- Class II
- Quantity
- 73 total: 23 units US;50 units OUS
- Official record key
device-enforcement:Z-0650-2021
Official wording
Reason: Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
Code information: Lot Codes: 201926AB 201942AF 201947AF 202007AF 202011 AF 202015AF 202018AF 202024AF
Distribution pattern: Nationwide Foreign: Canada, Thailand, Taiwan, South Africa
Derived failure modes
-
Unknown
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system