FDA Medical Device Recalls (openFDA)
Microport Orthopedics INC.: 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.
- Recall number
- Z-1249-2015
- Recalling firm
- Microport Orthopedics INC.
- 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.
- Status
- Terminated
- Initiated
- 2015-02-02
- Posted
- 2015-03-06
- Terminated
- 2015-03-19
- 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.
- Root cause
- Device Design
- Action
- MicroPort Orthopedics sent an Urgent Action Required letter dated January 29, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock including all consignment stock to determine if they have any affected product. If they have affected product they should return immediately to the MicroPort Orthopedics Inc. Distribution Center at 11481 Gulf Stream, Arlington, TN 38002. Mark all return shipping boxes with "RECALL" for identification and processing. Customers with questions were instructed to contact MPO's Customer Experience Department at 1-866-872-0211. For questions regarding this recall call 901-867-4324.
- Quantity
- 17 units
- Distribution
- Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands.
- Lot, serial or model codes
- Lot Numbers: 1560140, 15601401568897, 15601401570896
- 510(k) numbers
- ["K093552"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3010536692
- Firm city
- Arlington
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28