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Medical device recalls: December 2009

The FDA posted 119 medical device recall records in December 2009, from 59 recall events by 44 companies. 119 have not been classified yet.

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. · 6 events, 6 records
  2. Stryker Howmedica Osteonics Corp. · 4 events, 16 records
  3. GE Medical Systems, LLC · 3 events, 5 records
  4. Alphatec Spine, Inc. · 3 events, 4 records
  5. Biomet Microfixation, Inc. · 2 events, 6 records
  6. Philips Healthcare Inc. · 2 events, 5 records
  7. Ev3, Inc. · 2 events, 2 records
  8. Merit Medical Systems, Inc. · 1 event, 15 records

FDA root cause

  1. Other · 40
  2. Device Design · 25
  3. Nonconforming Material/Component · 12
  4. Process control · 9
  5. Labeling mix-ups · 6
  6. Employee error · 5
  7. Process design · 4
  8. Software design · 3

Not yet classified (119)

The FDA has posted these records but has not published a class for them yet.

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.