MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT
FDA device recall Z-0712-05 · posted 2005-04-16 · Terminated
Recall details
- Recalling firm
- Porex Surgical, Inc.
- Reason for recall
- The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres
- Action taken
- On 03/07/2005 and 03/08/2005 consignees were notified via email and telephone. A follow up letter was being sent.
- Root cause
- Other
- Status
- Terminated
- Product code
- HPZ
- Quantity affected
- 30 units
- Distribution
- AZ, IL, NJ and Korea
- Date initiated
- 2005-03-07
- Date posted
- 2005-04-16
- Date terminated
- 2005-08-17
- Location
- Newnan, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POREX(TM) EYE SPHERE IMPLANT (K863943) | Porex Medical | 1987-02-27 |