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Medical device recalls: September 2008

The FDA posted 819 medical device recall records in September 2008, from 303 recall events by 169 companies. 819 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. GE Healthcare · 22 events, 44 records
  2. Zimmer Inc. · 12 events, 85 records
  3. Stryker Howmedica Osteonics Corp. · 10 events, 13 records
  4. Medtronic Neuromodulation · 7 events, 12 records
  5. Physio Control, Inc. · 7 events, 12 records
  6. Merit Medical Systems, Inc. · 6 events, 18 records
  7. Biomet, Inc. · 5 events, 11 records
  8. Philips Medical Systems North America Co. Phillips · 5 events, 5 records

FDA root cause

  1. Device Design · 294
  2. Process control · 105
  3. Packaging process control · 79
  4. Software design · 61
  5. Other · 34
  6. Nonconforming Material/Component · 34
  7. Mixed-up of materials/components · 32
  8. Employee error · 29

Not yet classified (819)

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.