Z-1498-2021Class II

INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product...

Name: Z-1498-2021 INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product...
Creator: ConMed Corporation
Published: 2021-03-26
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2021-03-26 / Terminated / root cause: manufacturing process

FDA source

ConMed Corporation began a recall of INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and... on 2021-03-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1498-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-26
Posted: 2021-04-27
Terminated: 2024-04-05
Recalling firm: ConMed Corporation
Product: 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.
Product code: LXH Orthopedic Manual Surgical Instrument
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Conmed issued international notices Urgent Field Notice via UPS Priority on March 26, 202. Letter states reason for recall, health risk and action to take: Step 1: Please review your inventory for any of the devices with the affected lot codes listed on Attachment I. We ask that you contact all those departments within your facility and all other facilities that may have received affected products from you. Please forward a copy of this notice to all facilities which may have affected products in their inventory. It is imperative that all end users of these devices receive this notice and respond immediately. If you HAVE inventory of any USED devices from the affected lot codes listed on Attachment I, you may return them using the following method: a) Please clean, disinfect and sterilize the device the device following the directions for Cleaning, Disinfection, and Sterilization Information found in the Infinity" Drill Guide System Instructions for Use, P000009343 (https://www.conmed.com/en/customer-service/catalogs-and-ifus) on pages 4-6 of the English language section or the appropriate translation. b) Place the cleaned and sterilized device in a sterile wrap and insert this in a zip lock bag. Label the bag with the catalog number and lot code. Please mark the bag Used Device. c) Please complete the business reply form (Attachment II) and return it with the devices to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac Return via: UPS Account # W5Y243 (no charge to your facility) Please process a commercial invoice for the return to the United States referencing your purchase price as a value for Customs purposes and note on the commercial invoice that the return is for evaluation purposes only. Please include the following information on the invoice, with the returned product: CONMED FDA Reg. # 1317214 MDL#: D221270 510K #: Exempt Step 2c: If you DO NOT HAVE any affected devices to return, please complete the business re
Quantity in commerce: 2 units
Distribution: International distribution in the countries of Canada, Italy.
Product codes and lots: Serial Numbers: 001, 005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1498-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1498-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-27
Z-1499-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-27

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)