ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 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) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
- Company
- Microport Orthopedics Inc.
- Recall Initiated
- June 21, 2016
- Posted
- September 8, 2016
- Terminated
- July 26, 2017
- Recall Number
- Z-2702-2016
- Quantity
- 47 units
- Firm Location
- Arlington, TN
Reason for Recall
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
Distribution
Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
Lot / Code Info
all codes
Root Cause
Use error
Action Taken
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.
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