Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes) Indicated for aspirating bone marrow
FDA Recall Z-3273-2011 · Posted 2011-09-21
Recalling FirmSynthes USA (HQ), Inc.
Recall StatusTerminated
Product CodeFMF
Date Initiated2011-01-26
Date Terminated2015-04-16
Product Quantity96 parts
Reason for Recall
Firm became aware that some systems were released to stock without going through the sterilization process.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.