FDA Device recall Z-0651-2021
Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction
- FDA Device
- Class II
- terminated
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class II recall of Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction by Conmed, citing tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0651-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-12 |
| Published | 2020-12-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Conmed |
| Distribution | US |
Product
Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100
Reason
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
Identifiers
| code_info | Lot Codes: 201941AE 201946AF 202006AF 202010AF 202015AF 202019AF 202023AF |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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FDA Device · Class II · 2026-06-24 · Conmed - ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length
FDA Device · Class II · 2026-06-24 · Conmed
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0651-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.