ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 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.
FDA Recall Z-2695-2016 · Posted 2016-09-08
Recalling FirmMicroPort Orthopedics Inc.
Recall StatusTerminated
Product CodeMBH
Date Initiated2016-06-21
Date Terminated2017-07-26
Product Quantity110 units
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.
Firm 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 [email protected]. 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.
Root Cause
Use error
Distribution Pattern
Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.