FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0438-2011
- Recalling firm
- Ascension Orthopedics, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-07-12
- Posted
- 2010-11-22
- Terminated
- 2011-06-30
- 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.
- Lot, serial or model codes
- Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469
- 510(k) numbers
- ["K041451"]
- PMA numbers
- not on file
- Product code
- KYI
- Firm FEI
- 3002788818
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28