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.
- Company
- Ascension Orthopedics, Inc
- Recall Initiated
- July 12, 2010
- Posted
- November 22, 2010
- Terminated
- June 30, 2011
- Recall Number
- Z-0438-2011
- Quantity
- 10
- Firm Location
- Austin, TX
Reason for Recall
Two different product lots were found to be incorrectly labeled and placed into the incorrect box.
Distribution
Worldwide distribution: USA including states of: IL, IN, MD, OH, and TN; and countries of : Puerto Rico and Netherlands.
Lot / Code Info
Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469
Root Cause
Mixed-up of materials/components
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.
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