CLASS II Device recall · Reported 5 May 2021 · FDA Enforcement Report
INFINITY_TRAY Custom Procedural Kit - Canada recalled by ConMed
ConMed is recalling INFINITY_TRAY Custom Procedural Kit - Canada, distributed nationwide in the US. The recall was initiated on 26 Mar 2021 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-1498-2021
- FDA event ID
- 87578
- Recalling firm
- ConMed, Utica, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2021
- FDA classified
- 27 Apr 2021
- Reported
- 5 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 26 Mar 2021 | Recall initiated by company | |
| 27 Apr 2021 | Classified by FDA | +32 days |
| 5 May 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used
Product as listed by the FDA
INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction. The procedural kits have no kit specific labeling. Each product within the kits has its own product specific labeling.
Where it was distributed
International distribution in the countries of Canada, Italy.
Questions about this recall
Is INFINITY_TRAY Custom Procedural Kit - Canada recalled?
Yes. ConMed recalled INFINITY_TRAY Custom Procedural Kit - Canada on 26 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1498-2021.
Why was it recalled?
Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used
Which lots are affected?
Serial Numbers: 001, 005
Where was it sold?
International distribution in the countries of Canada, Italy.
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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