EVOLUTION MP TIBIAL BASE — Class II medical device recall Z-1249-2015
Terminated recall by Microport Orthopedics INC., reported 2015-03-18, distributed in AL, AZ, IA, ID, KS, MO, TX, WV. Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wa
| Recall number | Z-1249-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microport Orthopedics INC., Arlington, TN, United States |
| Recall initiated | 2015-02-02 |
| Classified | 2015-03-06 |
| Reported by FDA | 2015-03-18 |
| Terminated | 2015-03-19 |
| Distributed | AL, AZ, IA, ID, KS, MO, TX, WV |
| Countries outside the US | CA, NL |
| Quantity | 17 units |
| Lot numbers | 1560140, 15601401568897, 15601401570896 |
| Model numbers | ETPKN8SR |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1249-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.