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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon Total Knee System

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  Class 2 Device Recall Triathlon Total Knee System see related information
Date Initiated by Firm February 06, 2024
Date Posted March 06, 2024
Recall Status1 Open3, Classified
Recall Number Z-1264-2024
Recall Event ID 94026
510(K)Number K172634  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
Product NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Code Information Part No. 5537-G-411-E; GTIN: 07613327287691; Lot No. E97TH6; Expiration Date: 10/07/2028.
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
Manufacturer Reason
for Recall		 Potential packaging breaches of inner blister and outer sterile blister.
FDA Determined
Cause 2		 Packaging
Action URGENT MEDICAL DEVICE RECALL notifications dated 02/06/2024 were distributed to consignees by mail. Consignees were asked to forward the provided recall notice to all individuals within the organization who need to be made aware and organizations who have consigned product, immediately check all stock and operating room storage for affected devices, quarantine and discontinue use of recalled devices, complete and return the provided Business Reply Form by email to strykerortho4004@sedgwick.com or by fax to 855-800-1093. Consignees are to contact their local sales office or Stryker Sales Representative for product replacement and inventory questions. Recalled devices are to be returned to Stryker Orthopaedics/PFA Product Returns, Attn: Distribution Inventory Team, 325 Corporate Drive, Dock M-East, Mahwah, NJ 07430; include "Ref PFA 3524019" on shipment. Consignees with any questions are to call the firm at 201-831-5000 or by email at SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com. An URGENT MEDICAL DEVICE RECALL UPDATE, dated 3/18/24, was sent to consignees.
Quantity in Commerce 18 units (US); 5 units (OUS)
Distribution Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
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 = MBH and Original Applicant = Howmedica Osteonics Corp aka Stryker Orthopaedics
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