BioPro Femoral Head 28 mm +18, Item 19010. Orthopedic femoral head for implantation
FDA device recall Z-0164-2012 · posted 2011-11-04 · Terminated
Recall details
- Recalling firm
- Biopro, Inc.
- Reason for recall
- BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.
- Action taken
- Biopro, Inc notified all affected customers via telephone on September 21, 2011 with instructions to quarantine and return affected product to the manufacturer. The firm sent a follow up "RECALL NOTICE" dated September 29, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter gives instructions on how to return affected product. Contact Customer Service at 1-800-252-7707 for questions regarding this recall.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 8 units
- Distribution
- USA (nationwide) including the states of FL, MI, and TX.
- Date initiated
- 2011-09-21
- Date posted
- 2011-11-04
- Date terminated
- 2013-02-15
- Location
- Port Huron, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOPRO FEMORAL HEADS (K090208) | Biopro, Inc. | 2009-05-22 |