| Class 3 Device Recall Ascension MCP | |
Date Initiated by Firm | October 31, 2002 |
Date Posted | February 08, 2003 |
Recall Status1 |
Terminated 3 on December 03, 2003 |
Recall Number | Z-0550-03 |
Recall Event ID |
25057 |
PMA Number | P000057 |
Product Classification |
unknown device name - Product Code ---
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Product | Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal |
Code Information |
Brochure intended for international distribution, Document: LC-04-107-011 |
Recalling Firm/ Manufacturer |
Ascension Orthopedics, Inc 8200 Cameron Road, Ste C-140 Austin TX 78754-3832
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Manufacturer Reason for Recall | Literature approved for international distribution only was distributed domestically. |
FDA Determined Cause 2 | Other |
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 initiate an examination of all Ascension MCP professional labeling in their stock, and request return of incorrect labeling. The firm additionally, initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request. |
Quantity in Commerce | Currently being determined |
Distribution | AL, AZ, NM, TX, FL, NJ, CA, IL, TN, MS, OH, KY, IN, MN, NY, OR, WA, CO, PA, UT, MO, OK, NC, VA, SC, MD, MA, CT, VT, ME, ID, LA, WI, NE |
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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.
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