FDAClass IIJuly 6, 2022

Stryker INFINITY Resect Guide for INBONE Talus recall

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

Why was Stryker INFINITY Resect Guide for INBONE Talus recalled?

The instrument is incorrectly color coded.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #2039558, GTIN 00889797006552.

Product
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Recalling firm
Wright Medical Technology, Inc.
Quantity
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.
Recall date
July 6, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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