Recall Z-0438-2011 ยท KYI Prosthesis, Wrist, Carpal Trapezium
Ascension Orthopedics, Inc
The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469, is a single-use uncemented, one-component prosthesis for the basal thumb joint. The NuGrip is intended to replace the proximal end of the first metacarpal.
| Date | Nov 22, 2010 (initiated Jul 12, 2010) |
| Status | Terminated |
| Reason | Two different product lots were found to be incorrectly labeled and placed into the incorrect box. |
| Root cause | Mixed-up of materials/components |
| Action | 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. |
| Quantity | 10 |
| Distribution | Worldwide distribution: USA including states of: IL, IN, MD, OH, and TN; and countries of : Puerto Rico and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041451 | ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 Ascension Orthopedics, Inc., Aug 25, 2004 |