CLASS II Device recall · Reported 30 Dec 2020 · FDA Enforcement Report
Infinity ACL Tibial Elbow Guide-indicated for use recalled by ConMed
ConMed is recalling Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for, distributed nationwide in the US. The recall was initiated on 12 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0650-2021
- FDA event ID
- 86746
- Recalling firm
- ConMed, Utica, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Nov 2020
- FDA classified
- 21 Dec 2020
- Reported
- 30 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 12 Nov 2020 | Recall initiated by company | |
| 21 Dec 2020 | Classified by FDA | +39 days |
| 30 Dec 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
Where it was distributed
Nationwide Foreign: Canada, Thailand, Taiwan, South Africa
Questions about this recall
Is Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for recalled?
Yes. ConMed recalled Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for on 12 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0650-2021.
Why was it recalled?
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
Which lots are affected?
Lot Codes: 201926AB 201942AF 201947AF 202007AF 202011 AF 202015AF 202018AF 202024AF
Where was it sold?
Nationwide Foreign: Canada, Thailand, Taiwan, South Africa
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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