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U.S. Department of Health and Human Services

Class 2 Device Recall SWANSON

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  Class 2 Device Recall SWANSON see related information
Date Initiated by Firm July 27, 2022
Create Date August 23, 2022
Recall Status1 Open3, Classified
Recall Number Z-1567-2022
Recall Event ID 90660
Product Classification Semi-constrained metal/polymer finger joint prosthesis - Product Code MPK
Product Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
Code Information Lot numbers 1728375 and 1728376, UDI #00840420121707.
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		 An incorrect sizing label was applied to the carton packaging.
FDA Determined
Cause 2		 Error in labeling
Action The recalling firm issued letters dated 7/27/2022 to Health Care Professionals, Operators of Medical Devices, and Distributors. Distributors received the letter via email. The medical facility received the letter via FedEx. The letter informed the consignee of the product affected, product description, product issue, potential risks, and the actions needed by customers and distributors. The actions included (1) Immediately check their internal inventory to locate the product and remove it from their point of use and isolate/quarantine it to prevent accidental usage; (2) Return the enclosed business reply form by email to confirm receipt of the notification and document product segregation. The form is to be returned by 8/10/2022; (3) Return all affected product in their possession. Hospitals are instructed to contact their local sales office or Stryker sales representative directly for product returns and inventory questions. Branches/Hub are to return the affected devices to the address specified in the letter; (4) Ensure that personnel within the facility are aware of this communication and all required actions are completed; and (5) If product has been further distributed, notify the applicable parties at once regarding the recall.
Quantity in Commerce 17 devices
Distribution Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, NY, PA, and TN. The countries of the Australia, France, the Netherlands, Sweden, and the 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.
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