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U.S. Department of Health and Human Services

Class 2 Device Recall Valeris Medical Apollo Medial Suture Anchor

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  Class 2 Device Recall Valeris Medical Apollo Medial Suture Anchor see related information
Date Initiated by Firm July 16, 2018
Create Date October 12, 2018
Recall Status1 Terminated 3 on August 04, 2020
Recall Number Z-0104-2019
Recall Event ID 80734
510(K)Number K133036  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx. The firm name on the label is Valeris Medical, Marietta, GA.
Code Information Lot #1982, Exp. 3/22/2019
Recalling Firm/
Manufacturer		 Valeris Medical, LLC
200 Cobb Pkwy N Bldg 200 Ste 210
Marietta GA 30062-3500
For Additional Information Contact Ms. Jamie Lewis
678-540-1838
Manufacturer Reason
for Recall		 The product was mislabeled as containing the incorrect type of suture.
FDA Determined
Cause 2		 Process control
Action The recalling firm issued a letter dated 7/13/2018 via email on 7/16/2018 to their consignees to inform them the product is mislabeled and contains blue and green sutures rather than blue and white sutures as is indicated on the label.
Quantity in Commerce 75 units
Distribution Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.
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.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = AMENDIA INC.
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