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Medical device recalls: August 2009

The FDA posted 157 medical device recall records in August 2009, from 70 recall events by 55 companies. 157 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. · 7 events, 9 records
  2. GE Medical Systems, LLC · 4 events, 5 records
  3. Smith & Nephew Inc · 3 events, 5 records
  4. Hill-Rom Manufacturing, Inc. · 2 events, 4 records
  5. Draeger Medical Systems, Inc. · 2 events, 2 records
  6. Remel, Inc · 2 events, 2 records
  7. Varian Medical Systems Oncology Systems · 2 events, 2 records
  8. Stryker Instruments Div. of Stryker Corporation · 1 event, 53 records

FDA root cause

  1. Nonconforming Material/Component · 62
  2. Process control · 23
  3. Device Design · 19
  4. Software design · 12
  5. Other · 9
  6. Equipment maintenance · 7
  7. Labeling mix-ups · 4
  8. Component design/selection · 4

Not yet classified (157)

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.