PlainRecalls
FDA Devices Moderate Class II Ongoing

Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.

Reported: July 6, 2022 Initiated: June 2, 2022 #Z-1291-2022

Product Description

Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.

Reason for Recall

The instrument is incorrectly color coded.

Details

Units Affected
35 units
Distribution
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, MA, MI, MN, MO, NC, NY, OH, PA, TX, and WA. The countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Sweden, Switzerland, and United Kingdom.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.. Recalled by Wright Medical Technology, Inc.. Units affected: 35 units.
Why was this product recalled?
The instrument is incorrectly color coded.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 6, 2022. Severity: Moderate. Recall number: Z-1291-2022.