FDA Device recall Z-1249-2015
EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics,…
- FDA Device
- Class II
- terminated
- Published 2015-03-18
On 2015-03-18 the FDA classified a Class II recall of EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics,… by Microport Orthopedics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1249-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-02 |
| Published | 2015-03-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Microport Orthopedics |
| Distribution | AL, AZ, IA, ID, KS, MO, TX, WV |
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
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.
Identifiers
| code_info | Lot Numbers: 1560140, 15601401568897, 15601401570896 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Microport Orthopedics
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FDA Device · Class II · 2026-01-28 · Microport Orthopedics - EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR
FDA Device · Class II · 2024-12-25 · Microport Orthopedics - EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only
FDA Device · Class II · 2024-07-10 · Microport Orthopedics - EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
FDA Device · Class II · 2023-02-22 · Microport Orthopedics - EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
FDA Device · Class II · 2023-02-22 · Microport Orthopedics
All Microport Orthopedics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1249-2015%22
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