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Medical device recalls: December 2013

The FDA posted 185 medical device recall records in December 2013, from 111 recall events by 72 companies. 8 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. · 5 events, 20 records
  2. Philips Medical Systems, Inc. · 5 events, 5 records
  3. Siemens Healthcare Diagnostics, Inc. · 5 events, 5 records
  4. Synthes USA HQ, Inc. · 5 events, 5 records
  5. SpineFrontier, Inc. · 3 events, 8 records
  6. Remel Inc · 3 events, 4 records
  7. Stryker Howmedica Osteonics Corp. · 3 events, 4 records
  8. CareFusion 303, Inc. · 3 events, 3 records, 1 Class I

FDA root cause

  1. Device Design · 38
  2. Software Manufacturing/Software Deployment · 20
  3. Software design · 14
  4. Process change control · 12
  5. Labeling mix-ups · 10
  6. Component design/selection · 8
  7. Nonconforming Material/Component · 7
  8. Under Investigation by firm · 6

Class I recalls (8)

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

Class II recalls (173)

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

Class III recalls (4)

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.