CLASS II Device recall · Reported 18 Mar 2015 · FDA Enforcement Report
Evolution Mp Tibial Base recalled by Microport Orthopedics
Microport Orthopedics is recalling Evolution Mp Tibial Base, distributed in 8 states. The recall was initiated on 2 Feb 2015 and the FDA has classified it as Class II.
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-1249-2015
- FDA event ID
- 70477
- Recalling firm
- Microport Orthopedics, Arlington, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Feb 2015
- FDA classified
- 6 Mar 2015
- Reported
- 18 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 2 Feb 2015 | Recall initiated by company | |
| 6 Mar 2015 | Classified by FDA | +32 days |
| 18 Mar 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.
Product as listed by the FDA
EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.
Where it was distributed
Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands.
Questions about this recall
Why was it recalled?
Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.
Which lots are affected?
Lot Numbers: 1560140, 15601401568897, 15601401570896
Where was it sold?
Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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