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U.S. Department of Health and Human Services

Class 2 Device Recall AEQUALIS FLEX REVIVE Assembly Screw 0mm

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  Class 2 Device Recall AEQUALIS FLEX REVIVE Assembly Screw 0mm see related information
Date Initiated by Firm June 12, 2023
Date Posted June 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-2019-2023
Recall Event ID 92520
510(K)Number K191318  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Code Information GTIN 00846832069408, Serial Numbers: AZ1822082001, AZ1822082002, AZ1822082003, AZ1822082004, AZ1822082005, AZ1822082006, AZ1822082007, AZ1822082008, AZ1822082009, AZ1822082010, AZ1822082011, AZ1822082012, AZ1822082013, AZ1822082014, AZ1822082015, AZ1822082016, AZ1822082017, AZ1822082018, AZ1822082019, AZ1822082020, AZ1822082021, AZ1822082022, AZ1822082023, AZ1822082024, AZ1822082025, AZ1822082026, AZ1822082027, AZ1822082028, AZ1822082029, AZ1822082030, AZ1822082031, AZ1822082032, AZ1822082033, AZ1822082034, AZ1822082035, AZ1822082036, AZ1822082037, AZ1822082038, AZ1822082039, AZ1822082040, AZ1822082041, AZ1822082042, AZ1822082043, AZ1822082044, AZ1822082045, AZ1822082046, AZ1822082047, AZ1822082048, AZ1822082049, AZ1822082050, AZ1822082051, AZ1822082052, AZ1822082053, AZ1822082054, AZ1822082055
Recalling Firm/
Manufacturer		 Tornier, Inc
10801 Nesbitt Ave S
Bloomington MN 55437-3109
For Additional Information Contact Meghan Wells
901-201-9298
Manufacturer Reason
for Recall		 A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.
FDA Determined
Cause 2		 Under Investigation by firm
Action Tornier issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees beginning on 06/12/2023 by email and letter. The notice explained the problem, the risk associated with its use, and requested that the affected devices be isolated/quarantined pending return. Distributors were directed to notify their customers.
Quantity in Commerce 55 units
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, 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 = KWS and Original Applicant = Tornier, Inc.
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