EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, Micr
FDA device recall Z-1249-2015 · posted 2015-03-06 · Terminated
Recall details
- Recalling firm
- Microport Orthopedics INC.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 17 units
- Distribution
- Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands.
- Date initiated
- 2015-02-02
- Date posted
- 2015-03-06
- Date terminated
- 2015-03-19
- Location
- Arlington, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVOLUTION MP TOTAL KNEE SYSTEM (K093552) | Wrightmedicaltechnologyinc | 2010-03-04 |