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Class 3 Device Recall Ascension Orthopedics Carpal/Metacarpal (CMC) Saddle |
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Date Initiated by Firm |
June 03, 2013 |
Date Posted |
June 21, 2013 |
Recall Status1 |
Terminated 3 on October 08, 2014 |
Recall Number |
Z-1568-2013 |
Recall Event ID |
65362 |
510(K)Number |
K061451
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Product Classification |
Prosthesis, wrist, carpal trapezium - Product Code KYI
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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 NJ 08536-3344
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For Additional Information Contact |
609-275-0500
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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.
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FDA Determined Cause 2 |
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
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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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510(K) Database |
510(K)s with Product Code = KYI and Original Applicant = ASCENSION ORTHOPEDICS, INC.
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