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Medical device recalls: December 2007

The FDA posted 203 medical device recall records in December 2007, from 55 recall events by 46 companies. 203 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. Medtronic Sofamor Danek USA Inc · 3 events, 26 records
  2. Stryker Howmedica Osteonics Corp. · 3 events, 16 records
  3. Plus Orthopedics USA · 3 events, 3 records
  4. Roche Diagnostics Corp. · 2 events, 4 records
  5. Biomet, Inc. · 2 events, 3 records
  6. Terumo Cardiovascular Systems Corp · 2 events, 3 records
  7. Depuy Orthopaedics, Inc. · 1 event, 49 records
  8. Axya Medical · 1 event, 25 records

FDA root cause

  1. Packaging process control · 63
  2. Package design/selection · 36
  3. Device Design · 24
  4. Labeling design · 20
  5. Process control · 16
  6. Software design · 12
  7. Process design · 10
  8. Packaging change control · 6

Not yet classified (203)

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.