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U.S. Department of Health and Human Services

Class 3 Device Recall Ascension PIP

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  Class 3 Device Recall Ascension PIP see related information
Date Initiated by Firm October 31, 2002
Date Posted February 08, 2003
Recall Status1 Terminated 3 on December 03, 2003
Recall Number Z-0549-03
Recall Event ID 25056
HDE Number H010005 
Product Classification unknown device name - Product Code ---
Product Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented.

The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005
Code Information Removal domestically of literature Document: LC-04-207-001
Recalling Firm/
Ascension Orthopedics, Inc
8200 Cameron Road, Ste C-140
Austin TX 78754-3832
Manufacturer Reason
for Recall
Brochures approved for international distribution only were distributed domestically.
FDA Determined
Cause 2
Action The firm began to contact all US distributors on October 31, 2002 and all US sales representatives on November 1, 2002, by e-mail to inititate an examination of all pertinent professional labeling in their stock, and request return of incorrect labeling. The firm initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.
Quantity in Commerce Unknown at this time
Distribution AL, AZ, NM, TX, FL, NJ, CA, IL, TN, MS, OH, KY, IN, MN, NY, OR, WA, CO, PA, UT, MO, OK, NC, SC, VA, MD, PA, MA, CT, VT, ME, ID, LA, WI, NE

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.