CLASS I Device recall · Reported 14 Sep 2016 · FDA Enforcement Report
Advance(R) II Modular Tibial Base W/Screwholes, Knee Tibial Base recalled
MicroPort Orthopedics is recalling Advance(R) II Modular Tibial Base W/Screwholes, Knee Tibial Base. The recall was initiated on 21 Jun 2016 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2693-2016
- FDA event ID
- 74785
- Recalling firm
- MicroPort Orthopedics, Arlington, TN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Jun 2016
- FDA classified
- 8 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 21 Jun 2016 | Recall initiated by company | |
| 8 Sep 2016 | Classified by FDA | +79 days |
| 14 Sep 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; 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.
Where it was distributed
Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
Questions about this recall
Why was it recalled?
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
Which lots are affected?
all codes
Where was it sold?
Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 74785This product is part of a recall event; the main page for the event is Advance(R) II Modular Tibial Base W/Screwholes, Knee Tibial Base recalled.
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