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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 Device Recall Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes)see related information
Date Initiated by FirmJanuary 26, 2011
Date PostedSeptember 21, 2011
Recall Status1 Terminated 3 on April 16, 2015
Recall NumberZ-3273-2011
Recall Event ID 57865
510(K)NumberK051720 
Product Classification Syringe, piston - Product Code FMF
ProductSynthes 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
FEI Number 3005180112
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information ContactCustomer 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
ActionSynthes (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 Commerce96 parts
DistributionNationwide 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 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 = FMF
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