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Medical device recalls: January 2009

The FDA posted 312 medical device recall records in January 2009, from 97 recall events by 76 companies. 312 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. Stryker Howmedica Osteonics Corp. · 4 events, 18 records
  2. Siemens Medical Solutions USA, Inc · 4 events, 4 records
  3. Boston Scientific Corp · 3 events, 14 records
  4. Zimmer Inc. · 3 events, 5 records
  5. Siemens Medical Solutions USA, Inc · 3 events, 4 records
  6. GE Healthcare Integrated IT Solutions · 3 events, 3 records
  7. Biomet, Inc. · 2 events, 15 records
  8. Merit Medical Systems, Inc. · 2 events, 5 records

FDA root cause

  1. Process control · 82
  2. Packaging process control · 36
  3. Labeling Change Control · 31
  4. Other · 29
  5. Software design · 25
  6. Nonconforming Material/Component · 21
  7. Device Design · 19
  8. Packaging · 16

Not yet classified (312)

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.