—#97615

Product

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

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K051720
Affected lot / code info: Part Number 710.150.99S, Lot number N999822

Why it was recalled

Firm became aware that some systems were released to stock without going through the sterilization process.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Synthes USA (HQ), Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

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.

Timeline

Recall initiated: 2011-01-26
Posted by FDA: 2011-09-21
Terminated: 2015-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97615. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.