Reported Dec 7, 2016 · Terminated
Conserve Cups
MicroPort Orthopedics Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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?
Conserve Cups
48 of 48 products
| Model / number | Product as published |
|---|---|
38BF3642 | — |
38BF3642SP | — |
38BF3844 | — |
38BF3844SP | — |
38BF4046 | — |
38BF4046SP | — |
38BF4248 | — |
38BF4248SP | — |
38BF4450 | — |
38BF4450SP | — |
38BF4652 | — |
38BF4652SP | — |
38BF4854 | — |
38BF5056 | — |
38BF5258 | — |
38BF5258SP | — |
38BF5460 | — |
38BF5460SP | — |
38BF5662 | — |
38BF5662SP | — |
- Amount recalled
- 68,221 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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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