Recall Z-2699-2016 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
MicroPort Orthopedics Inc.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noni
| Date | Sep 8, 2016 (initiated Jun 21, 2016) |
| Status | Terminated |
| Reason | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. |
| Root cause | Use error |
| Action | MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers. The firm requested customers complete the enclosed form and return by fax 1-901-451-6032 or by email to Postmarket@ortho.microport.com. Customers were also requested to return the affected product. Non-responding consignees will be notified after 30 days. For questions regarding this recall call 901-867-4771. |
| Quantity | 134 units |
| Distribution | Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061223 | ADVANCE TOTAL KNEE SYSTEM Wrightmedicaltechnologyinc, Aug 18, 2006 |