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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)

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 Class 2 Recall
Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes)
see related information
Date Posted September 21, 2011
Recall Status1 Open
Recall Number Z-3273-2011
Recall Event ID 57865
Premarket Notification
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, Pennsylvania 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.
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 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)
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