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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Infinity Alignment Frame Distal SubAssembly

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  Class 2 Device Recall Stryker Infinity Alignment Frame Distal SubAssembly see related information
Date Initiated by Firm June 13, 2023
Date Posted July 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-2105-2023
Recall Event ID 92460
510(K)Number K123954  
Product Classification Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
Product Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Code Information Lot numbers 2656815 and 2762126, UDI-DI 00889797003926.
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 devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.
FDA Determined
Cause 2		 Process control
Action The firm issued a Field Safety Correction Action (FSCA) Medical Devices Vigilance System form to the lead competent authority, ANSM-France, via email on 6/13/2023 for their review and approval for the recall to be carried out in their jurisdiction. The FSCA identified the affected product, a description of the issue, and advice on actions to be taken by the distributor and the user. The advice included to check the inventory to locate the product listed and remove and isolate/quarantine it to prevent accidental use. A business reply form was to be returned by email to confirm receipt of the notification and document product segregation. Upon receipt of the reply form, Stryker will contact the consignee for return of the product. If the devices have been distributed to other organizations, contact details are requested so that Stryker can inform the recipients appropriately. If the consignee is a distributor, they are responsible for notifying their affected customers. An undated recall letter accompanied the FSCA that will be issued once the lead competent authority approves it. The content of the letter was similar to the FSCA and contained a business reply form.
Quantity in Commerce 106 devices
Distribution There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, 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.
510(K) Database 510(K)s with Product Code = HSN and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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