Recall Z-2694-2016— MicroPort Orthopedics Inc.

Name: FDA recall Z-2694-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-21

Class I · Terminated

Class I FDA medical device recall by MicroPort Orthopedics Inc., initiated 2016-06-21, terminated 2017-07-26. It names one FDA 510(k) clearance: K061223. Product: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 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.. Reason: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening..

Recalling firm: MicroPort Orthopedics Inc.
Classification: Class I
Status: Terminated
Initiated: 2016-06-21
Terminated: 2017-07-26
Firm location: Arlington, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K061223 — ADVANCE TOTAL KNEE SYSTEMWrightmedicaltechnologyinc·cleared 2006-08-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.