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U.S. Department of Health and Human Services

Class 3 Device Recall Ascension Orthopedics Carpal/Metacarpal (CMC) Saddle

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 Class 3 Recall
Ascension Orthopedics Carpal/Metacarpal (CMC) Saddle
see related information
Date Posted June 21, 2013
Recall Status1 Terminated on October 08, 2014
Recall Number Z-1568-2013
Recall Event ID 65362
Premarket Notification
510(K) Number
K061451 
Product Classification Prosthesis, Wrist, Carpal Trapezium - Product Code KYI
Product CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.
Code Information Lot/Serial Number: 111602, 110864, 102815, 091515, 092563, 110863. Product/Catalogue No: CMC-410-10, CMC-410-20, CMC-410-30, CMC-410-40.
Recalling Firm/
Manufacturer
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro, New Jersey 08536-3344
Manufacturer Reason
for Recall
As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by FDA.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action Integra sent an Urgent: Medical Device Recall letter to all affected product. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, discontinue use, and complete and return the attached form. When the form is received, Customer Service Returns and Repairs will send an RMA number to return the affected inventory. For quwstions contact your regional managers or call 512-520-7697.
Quantity in Commerce 467 devices
Distribution USA Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KYI and Original Applicant = ASCENSION ORTHOPEDICS, INC.
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