Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes) Indicated for aspirating bone
FDA device recall Z-3273-2011 · posted 2011-09-21 · Terminated
Recall details
- Recalling firm
- Synthes USA (HQ), Inc.
- Reason for recall
- Firm became aware that some systems were released to stock without going through the sterilization process.
- Action taken
- 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
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 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.
- Date initiated
- 2011-01-26
- Date posted
- 2011-09-21
- Date terminated
- 2015-04-16
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE (K051720) | Synthes (Usa) | 2005-07-25 |