Z-3273-2011

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

Name: Z-3273-2011 Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes) Indicated for...
Creator: Synthes USA (HQ), Inc.
Published: 2011-01-26
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2011-01-26 / Terminated / root cause: manufacturing process

FDA source

Synthes USA (HQ), Inc. began a recall of Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes) Indicated for aspirating bone marrow on 2011-01-26. The reason FDA records is "Firm became aware that some systems were released to stock without going through the sterilization process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3273-2011
Status: Terminated
Initiated: 2011-01-26
Posted: 2011-09-21
Terminated: 2015-04-16
Recalling firm: Synthes GmbH
Product: Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes) Indicated for aspirating bone marrow
Product code: FMF Syringe, Piston
Reason for recall: Firm became aware that some systems were released to stock without going through the sterilization process.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Part Number 710.150.99S, Lot number N999822

Product code FMF

K051720Class IISynthes (USA) Bone Marrow Aspiration SyringeSynthes (Usa) / cleared 2005-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)