Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Valeris Medical Apollo Medial Suture Anchor

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Valeris Medical Apollo Medial Suture Anchorsee related information
Date Initiated by FirmJuly 16, 2018
Create DateOctober 12, 2018
Recall Status1 Terminated 3 on August 04, 2020
Recall NumberZ-0104-2019
Recall Event ID 80734
510(K)NumberK133036 
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
ProductValeris 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
FEI Number 3010841252
Recalling Firm/
Manufacturer		 Valeris Medical, LLC
200 Cobb Pkwy N Bldg 200 Ste 210
Marietta GA 30062-3500
For Additional Information ContactMs. 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
ActionThe 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 Commerce75 units
DistributionDistribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MBI
-
-