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Terminated

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.

FDA Recall Z-0438-2011 · Posted 2010-11-22

Recalling FirmAscension Orthopedics, Inc
Recall StatusTerminated
Product CodeKYI
Date Initiated2010-07-12
Date Terminated2011-06-30
Product Quantity10

Reason for Recall

Two different product lots were found to be incorrectly labeled and placed into the incorrect box.

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide distribution: USA including states of: IL, IN, MD, OH, and TN; and countries of : Puerto Rico and Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041451ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50Ascension Orthopedics, Inc. · 2004-08-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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