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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Infinity

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  Class 2 Device Recall Stryker Infinity see related information
Date Initiated by Firm June 02, 2022
Create Date June 27, 2022
Recall Status1 Open3, Classified
Recall Number Z-1291-2022
Recall Event ID 90216
510(K)Number K140749  
Product Classification Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
Product Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Code Information Lot #2039558, GTIN 00889797006552.
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
1023 Cherry Rd
Memphis TN 38117-5423
For Additional Information Contact Meghan Wells
901-201-9298
Manufacturer Reason
for Recall		 The instrument is incorrectly color coded.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm issued letters dated 2-June-2022 via email. The letter was issued to the distributors but the noticed was flagged to the attention of health care professionals, operators of medical devices, and distributors. The letter provided the product description, issue, potential risks, and actions needed as follows: (1) Immediately check the inventory to locate the product listed on the attached business reply form and remove it from its point of use; (2) Return the enclosed business reply form by email to confirm receipt of this notification and document product segregation; (3) Upon receipt of the completed business reply form, Stryker will contact the consignee to arrange for the return and replacement of the product; (4) Maintain awareness of this communication internally until all required actions have been completed within the consignee facility; (5) If the product has been further distributed, notify all affected parties at once about the recall. A copy of this notification can be used to send to the consignees. If possible, the recalling firm should be informed if any of the devices have been further distributed, including contact details, so that the recalling firm can inform the recipients appropriately. If the consignee first receiving the letter is a distributor, they are responsible for notifying their affected customers.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HSN and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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