Z-0651-2021 Class II Terminated
FDA device recall Z-0651-2021 was initiated by ConMed Corporation on November 12, 2020 and is designated Class II. Reason for recall: Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system The recall status is terminated (terminated April 5, 2024). Affected quantity: 95 total: 20 units US and 75 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- November 12, 2020
- Termination Date
- April 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95 total: 20 units US and 75 units OUS
Product Description
Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100
Reason for Recall
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
Distribution Pattern
Nationwide Foreign: Canada, Thailand, Taiwan, South Africa
Code Information
Lot Codes: 201941AE 201946AF 202006AF 202010AF 202015AF 202019AF 202023AF