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U.S. Department of Health and Human Services

Class 2 Device Recall Ascension Orthopedics PyroSphere CMC & PyroSphere TMT

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  Class 2 Device Recall Ascension Orthopedics PyroSphere CMC & PyroSphere TMT see related information
Date Initiated by Firm November 06, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on August 21, 2015
Recall Number Z-0813-2015
Recall Event ID 69719
510(K)Number K060560  
Product Classification Prosthesis, toe, hemi-, phalangeal - Product Code KWD
Product Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW
Code Information Lot numbers: 140098T and 140929T
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact David E. Gronostajski
609-936-6822
Manufacturer Reason
for Recall		 Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm sent out written notification of the recall on 11/6/14. The letter instructed the consignees to quarantine and return any affected product.
Quantity in Commerce 19 units
Distribution WA, Australia, and France
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 = KWD and Original Applicant = ASCENSION ORTHOPEDICS, INC.
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