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U.S. Department of Health and Human Services

Class 2 Device Recall Ascension PyroCarbon PIP Total Joint Trials

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  Class 2 Device Recall Ascension PyroCarbon PIP Total Joint Trials see related information
Date Initiated by Firm June 17, 2009
Date Posted May 04, 2010
Recall Status1 Terminated 3 on September 27, 2010
Recall Number Z-1524-2010
Recall Event ID 55191
HDE Number H010005 
Product Classification Finger semi-constrained pyrolytic carbon uncemented prosthesis - Product Code NEG
Product Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension Orthopedics, 8700 Cameron Road, Suite 100, Austin, Texas 78754; TEL: 512 836-5001.

Intended as an accessory to the Ascension PyroCarbon PIP Total Joint used in finger joint implant procedures where the joint has become painful, stiff or cannot move because of arthritis.
Code Information All lot codes.
Recalling Firm/
Manufacturer		 Ascension Orthopedics, Inc
8700 Cameron Rd Ste 100
Austin TX 78754
For Additional Information Contact
512-836-5001 Ext. 1513
Manufacturer Reason
for Recall		 Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant.
FDA Determined
Cause 2		 Device Design
Action Ascension Orthopedics, Inc. issued e-mail notification to distributors and sales representatives beginning June 2009. Consignees were instructed return affected product to the firm for replacement. For further information, contact Ascension Orthopedics, Inc. at 1-512-836-5001 extension 1549.
Quantity in Commerce 129 units (64 US, 65 OUS)
Distribution Worldwide Distribution - Worldwide Distribution - United States, United Kingdom, France, Australia, Belgium, Czech Republic, Canada, Germany, The Netherlands and South Africa.
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.
HDE Database HDEs with Product Code = NEG and Original Applicant = Smith & Nephew, Inc.
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