Z-0438-2011

The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469, is a...

Name: Z-0438-2011 The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469, is a...
Creator: Ascension Orthopedics, Inc
Published: 2010-07-12
License: https://open.fda.gov/license/

Ascension Orthopedics, Inc. / initiated 2010-07-12 / Terminated / root cause: labeling and UDI

FDA source

Ascension Orthopedics, Inc began a recall of 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... on 2010-07-12. The reason FDA records is "Two different product lots were found to be incorrectly labeled and placed into the incorrect box". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0438-2011
Status: Terminated
Initiated: 2010-07-12
Posted: 2010-11-22
Terminated: 2011-06-30
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.
Product code: KYI Prosthesis, Wrist, Carpal Trapezium
Reason for recall: Two different product lots were found to be incorrectly labeled and placed into the incorrect box.
Root cause tag: labeling and UDI
FDA 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 in commerce: 10
Distribution: Worldwide distribution: USA including states of: IL, IN, MD, OH, and TN; and countries of : Puerto Rico and Netherlands.
Product codes and lots: Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469

Product code KYI

K041451Class IIAscension Pyrohemisphere, Models Phs-440-10, Phs-440-20, Phs-440-30, Phs-440-40, Phs-440-50Ascension Orthopedics, Inc. / cleared 2004-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)