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Class 1 Device Recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES |
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Date Initiated by Firm |
June 21, 2016 |
Date Posted |
September 08, 2016 |
Recall Status1 |
Terminated 3 on July 26, 2017 |
Recall Number |
Z-2700-2016 |
Recall Event ID |
74785 |
510(K)Number |
K061223
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Product Classification |
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
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Product |
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. |
Code Information |
all codes |
Recalling Firm/ Manufacturer |
MicroPort Orthopedics Inc. 5677 Airline Rd Arlington TN 38002-9501
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For Additional Information Contact |
Rachael Wehner Wise 901-867-4771
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Manufacturer Reason for Recall |
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
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FDA Determined Cause 2 |
Use error |
Action |
MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers. The firm requested customers complete the enclosed form and return by fax 1-901-451-6032 or by email to Postmarket@ortho.microport.com. Customers were also requested to return the affected product. Non-responding consignees will be notified after 30 days.
For questions regarding this recall call 901-867-4771. |
Quantity in Commerce |
77 units |
Distribution |
Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom |
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 = MBH and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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