Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central
FDA device recall Z-0590-2011 · posted 2010-12-10 · Terminated
Recall details
- Recalling firm
- Orthofix Inc
- Reason for recall
- Outer cartons for the product may be labeled with incorrect needle gauge.
- Action taken
- Orthofix issued an Urgent Product Recall letter dated October 14, 2010 to consignees. Customers were instructed to inspect their inventory, and remove and return affected product to the firm. Replacement needles will be provided. Orthofix account representatives can be contacted at 1 888 298 5700, and Orthofix Regulatory Affairs can be contacted at 1 214 937 2061.
- Root cause
- Other
- Status
- Terminated
- Product code
- LWE
- Quantity affected
- 274
- Distribution
- Worldwide Distribution - USA, including the states of AL, AR, CA, CT, FL, LA, MI, MO, NC, NJ, NY, PA, SC, and TX, and the country of Spain.
- Date initiated
- 2010-10-18
- Date posted
- 2010-12-10
- Date terminated
- 2011-02-28
- Location
- Lewisville, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BONE-TEMNO/STERNUM-TEMNO (K913306) | Proact, Ltd. | 1991-11-01 |