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Medical device recalls: June 2009

The FDA posted 156 medical device recall records in June 2009, from 51 recall events by 37 companies. 156 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, 17 records
  2. Biomet, Inc. · 3 events, 9 records
  3. Arrow International Inc · 2 events, 18 records
  4. Siemens Medical Solutions USA, Inc · 2 events, 8 records
  5. GE Medical Systems, LLC · 2 events, 5 records
  6. Advanced Sterilization Products · 2 events, 3 records
  7. Boston Scientific Corporation · 2 events, 3 records
  8. GE Healthcare · 2 events, 3 records

FDA root cause

  1. Process control · 40
  2. Device Design · 40
  3. Employee error · 22
  4. Nonconforming Material/Component · 11
  5. Other · 9
  6. Mixed-up of materials/components · 8
  7. Component design/selection · 6
  8. Packaging process control · 5

Not yet classified (156)

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.