Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt Lake City,
FDA device recall Z-2228-2008 · posted 2008-09-18 · Terminated
Recall details
- Recalling firm
- OrthoPro LLC
- Reason for recall
- Labeling presented conflicting information as to whether device was sterile or not.
- Action taken
- All sales agents were verbally notified on 05/29/2008 and told to locate and return all available affected implants. For assistance, contact OrthoPro at 1-801-746-0208.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KWD
- Quantity affected
- 210 units
- Distribution
- AZ, CA, CO, FL, HI, IL, IN, MI, NY, OH, OR, PA, RI, TX, UT, VA, and WA.
- Date initiated
- 2008-05-29
- Date posted
- 2008-09-18
- Date terminated
- 2008-09-24
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| METAL HEMI IMPLANT (K071243) | Orthopro, LLC | 2007-05-23 |