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 Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes)

  • 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 Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes) see related information
Date Initiated by Firm January 26, 2011
Date Posted September 21, 2011
Recall Status1 Terminated 3 on April 16, 2015
Recall Number Z-3273-2011
Recall Event ID 57865
510(K)Number K051720  
Product Classification Syringe, piston - Product Code FMF
Product Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes)

Indicated for aspirating bone marrow
Code Information Part Number 710.150.99S, Lot number N999822
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 Firm became aware that some systems were released to stock without going through the sterilization process.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Synthes (USA) sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 4, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. Affected product removed from inventory will be replaced by Synthes. Contact the Synthes Spine Sale Consultant at 1-800-620-7025 ext.6883 for questions concerning this recall.
Quantity in Commerce 96 parts
Distribution Nationwide Distribution-including the states of AR, CO, FL, GA, ID, LA, MA, MD, MO, MT, NY, NC, OH, SC, SD, TN, TX, and VA.
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 = FMF and Original Applicant = SYNTHES (USA)
-
-