MicroPort Orthopedics Inc.: Medical Device Recall in 2016 - (Recall #: Z-2694-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: June 21, 2016

Date Posted: September 14, 2016

Recall Number: Z-2694-2016

Event ID: 74785

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.

Status: Terminated

Product Quantity: 36 units

Code Information:

all codes

Distribution Pattern:

Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated