Device product
Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100
Z-0651-2021
Product summary
- Event
- Event 86746
- Status
- Terminated
- Classification
- Class II
- Quantity
- 95 total: 20 units US and 75 units OUS
- Official record key
device-enforcement:Z-0651-2021
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: 201941AE 201946AF 202006AF 202010AF 202015AF 202019AF 202023AF
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