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Medical device recalls: July 2009

The FDA posted 154 medical device recall records in July 2009, from 59 recall events by 42 companies. 154 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, 47 records
  2. Zimmer Inc. · 4 events, 7 records
  3. Philips Medical Systems (Cleveland) Inc · 3 events, 5 records
  4. Abbott Vascular-Cardiac Therapies dba Guidant Corporation · 2 events, 5 records
  5. Sybaritic, Inc · 2 events, 5 records
  6. Boston Scientific CRM Corp · 2 events, 4 records
  7. GE Healthcare Integrated IT Solutions · 2 events, 2 records
  8. Philips Healthcare Inc. · 2 events, 2 records

FDA root cause

  1. Process control · 64
  2. Device Design · 23
  3. Software design · 16
  4. Packaging process control · 11
  5. Other · 9
  6. Pending · 8
  7. Process design · 6
  8. Material/Component Contamination · 5

Not yet classified (154)

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.