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U.S. Department of Health and Human Services

Class 2 Device Recall Instrument trays used to store AltiVate Small Shell Trials

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  Class 2 Device Recall Instrument trays used to store AltiVate Small Shell Trials see related information
Date Initiated by Firm June 26, 2018
Create Date August 02, 2018
Recall Status1 Terminated 3 on August 22, 2023
Recall Number Z-2600-2018
Recall Event ID 80445
Product Classification General surgery tray - Product Code LRO
Product Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM).

Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrumentation by end users.
Code Information 804-99-129 Vendor Lot #22747003
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
Manufacturer Reason
for Recall		 A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
FDA Determined
Cause 2		 Process control
Action The firm, DJO LLC, sent an "URGENT FIELD SAFETY NOTICE" letter dated 6/26/2018 to its direct accounts by email on 06/26/2018. The letter described the product, problem and actions to be taken. The customers were instructed to return product; contact Customer Service as soon as possible to request an RMA for return and exchange of the full instrument set; and to coordinate the exchange of products with Customer Service. If you do not have these instrument sets or the number of sets identified above, you are required to complete the attached form and email it to sandra.busick@djdoglobal.com. ALL ACTIVITIES OUTLINED ABOVE SHOULD BE COMPLETED BY JULY 30, 2018. If you have any questions, please call (512) 834-6255 or by email to teffany.hutto@djoglobal.com.
Quantity in Commerce 30 units
Distribution US Distribution to states of; AZ, CA, CO, FL, IN, NJ, NY, NV, MI, MN, MO, OH, RI, SC, TN, TX, UT and WA and country of; 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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