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
|
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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.
|
510(K) Database |
510(K)s with Product Code = KWD and Original Applicant = ASCENSION ORTHOPEDICS, INC.
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