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Medical device recalls: December 2012

The FDA posted 171 medical device recall records in December 2012, from 86 recall events by 64 companies. 7 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. Biomet, Inc. · 4 events, 5 records
  2. GE Healthcare, LLC · 4 events, 4 records, 1 Class I
  3. Zimmer, Inc. · 3 events, 20 records, 1 Class I
  4. Beckman Coulter Inc. · 3 events, 3 records
  5. Siemens Medical Solutions USA, Inc · 3 events, 3 records
  6. DePuy Orthopaedics, Inc. · 2 events, 21 records
  7. Roche Molecular Systems, Inc. · 2 events, 11 records
  8. Hospira Inc. · 2 events, 6 records

FDA root cause

  1. Device Design · 63
  2. Nonconforming Material/Component · 28
  3. Software design · 19
  4. Component design/selection · 11
  5. Process design · 8
  6. Process control · 8
  7. Employee error · 7
  8. No Marketing Application · 6

Class I recalls (7)

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

Class II recalls (161)

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

Class III recalls (3)

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.