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Medical device recalls: November 2009

The FDA posted 354 medical device recall records in November 2009, from 92 recall events by 74 companies. 354 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. · 5 events, 78 records
  2. Siemens Medical Solutions USA, Inc · 4 events, 6 records
  3. Philips Healthcare Inc. · 3 events, 5 records
  4. Stryker Imaging · 3 events, 3 records
  5. Synthes USA (HQ), Inc. · 2 events, 12 records
  6. Stryker Medical Div. of Stryker Corporation · 2 events, 11 records
  7. Boston Scientific Corporation · 2 events, 5 records
  8. GE Medical Systems, LLC · 2 events, 5 records

FDA root cause

  1. Other · 95
  2. Device Design · 95
  3. Process control · 63
  4. Nonconforming Material/Component · 42
  5. Software design · 16
  6. Component design/selection · 8
  7. Component change control · 8
  8. Process design · 7

Not yet classified (354)

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.