Class I — MicroPort Orthopedics Inc.
| Recalling firm | MicroPort Orthopedics Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. |
| 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 fu… |
| Quantity | 77 units |
| Distribution | Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom |
| Initiated | 2016-06-21 |
| Classified | 2016-09-08 |
| Terminated | 2017-07-26 |
| Recall number | Z-2700-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — MicroPort Orthopedics Inc. (Z-2700-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74785/
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