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Medical device recalls: November 2012

The FDA posted 276 medical device recall records in November 2012, from 90 recall events by 65 companies. 17 are Class I, the most serious category.

Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.

Companies with the most recall events

  1. Zimmer, Inc. · 7 events, 57 records
  2. Kerr Corporation · 4 events, 4 records
  3. Terumo Cardiovascular Systems Corporation · 3 events, 10 records
  4. Stryker Howmedica Osteonics Corp. · 3 events, 4 records
  5. Biomerieux Inc · 2 events, 32 records
  6. GE Healthcare, LLC · 2 events, 7 records
  7. Clinical Diagnostic Solutions · 2 events, 5 records
  8. Kimberly-Clark Corporation · 2 events, 3 records

FDA root cause

  1. Device Design · 65
  2. Error in labeling · 43
  3. Nonconforming Material/Component · 42
  4. Software design · 39
  5. Process control · 22
  6. Component design/selection · 17
  7. Mixed-up of materials/components · 8
  8. Radiation Control for Health and Safety Act · 7

Class I recalls (17)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

Class II recalls (248)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Class III recalls (11)

Using the device is not likely to cause health problems, but it violates FDA rules.

Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.