Reported Sep 14, 2016 · Terminated
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT…
MicroPort Orthopedics Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MicroPort Orthopedics Inc. · 5677 Airline Rd · Arlington, TN · 38002-9501
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 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. |
- Lot codes and dates
- all codes
- Amount recalled
- 98 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Why it was recalled
Stop using this product now
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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