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U.S. Department of Health and Human Services

Class 2 Device Recall DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 53306108

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  Class 2 Device Recall DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 53306108 see related information
Date Initiated by Firm August 04, 2023
Date Posted September 19, 2023
Recall Status1 Open3, Classified
Recall Number Z-2607-2023
Recall Event ID 92969
510(K)Number K172351  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code KWS
Product DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
Code Information UDI-DI/Lot: 00190446259091/923W1411/April 3, 2029
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
512-834-6200
Manufacturer Reason
for Recall		 Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 8/4/23, recall notices were mailed to surgeons and distributors. They were reminded that starting on 7/3/23 they were contacted by the firm, and asked to quarantine affected devices, and that the affected devices had since been retrieved by the firm's sales representatives. Surgeons were asked to take the following actions: 1) We ask that you reach out to your patient[s] who were implanted with affected components as identified above and consider whether it may be appropriate for your patient to be monitored more closely to watch for signs and symptoms of acute or chronic infection. 2) We have also provided a patient letter for you to provide to your patient[s] who was [were] implanted with an affected component[s] should you prefer a written notification to accompany your verbal contact. 3) Please make the hospital where you implanted the components aware of this action, as appropriate by providing a copy of this communication or verbally notifying the hospital. 4) Please review and complete the enclosed Voluntary Recall Response Form. If you have any questions phone the firm at 1(800)456-8696 between the hours of 7:30AM-6:00PM CST, or e-mail customerservice@djosurgical.com In addition, distributors were asked to do the following: Provide the notification to any additional organizations or members within your facility or network where devices subject to this voluntary recall may have been transferred.
Quantity in Commerce 15
Distribution US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany
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 = KWS and Original Applicant = Encore Medical, L.P.
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