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U.S. Department of Health and Human Services

Class 2 Device Recall Ascension PyroHemiSphere (aka NuGrip)

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  Class 2 Device Recall Ascension PyroHemiSphere (aka NuGrip) see related information
Date Initiated by Firm July 12, 2010
Date Posted November 22, 2010
Recall Status1 Terminated 3 on June 30, 2011
Recall Number Z-0438-2011
Recall Event ID 56215
510(K)Number K041451  
Product Classification prosthesis, wrist, carpal trapezium - Product Code KYI
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.
Code Information Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469
Recalling Firm/
Manufacturer		 Ascension Orthopedics, Inc
8700 Cameron Rd Ste 100
Austin TX 78754
For Additional Information Contact Ken Thoma
512-836-5001 Ext. 1513
Manufacturer Reason
for Recall		 Two different product lots were found to be incorrectly labeled and placed into the incorrect box.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KYI and Original Applicant = ASCENSION ORTHOPEDICS, INC.
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