The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469, is a single-use
FDA device recall Z-0438-2011 · posted 2010-11-22 · Terminated
Recall details
- Recalling firm
- Ascension Orthopedics, Inc
- Reason for recall
- Two different product lots were found to be incorrectly labeled and placed into the incorrect box.
- Action taken
- Ascension Orthopedics notified by phone on June 25, 2010 and sent a letter dated July 22, 2010, to all customers. The customers were instructed to return the devices to the firm. Should you have any questions or concerns please feel free to contact (512) 836-5001 ext 1585.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- KYI
- Quantity affected
- 10
- Distribution
- Worldwide distribution: USA including states of: IL, IN, MD, OH, and TN; and countries of : Puerto Rico and Netherlands.
- Date initiated
- 2010-07-12
- Date posted
- 2010-11-22
- Date terminated
- 2011-06-30
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 (K041451) | Ascension Orthopedics, Inc. | 2004-08-25 |