Reported Dec 7, 2016 · Terminated
Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF…
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?
- Lineage ShellREF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head
- Lot codes and dates
10 of 10 products
Products covered by this recall Model / number Product as published 36693646Serial Numbers: 09230967, 09229086, 10230508 36693848Serial Numbers: 08228745, 10230509, 11235075 36694050Serial Numbers: 09229091, 09230501 36694252Serial Numbers: 09229131, 10230510 36694454Serial Numbers: LLALMB161A, 09230503 36694656Serial Numbers: 09230505, 11230847 36694858Serial Numbers: 09229167, 10230511 36695060Serial Numbers: 09229169, 09230506 36695262Serial Numbers: 09230507, 09229170 36695464Serial Numbers: 08228747, 10230512 - Amount recalled
- 22 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.
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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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