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Medical device recalls: September 2007

The FDA posted 91 medical device recall records in September 2007, from 44 recall events by 39 companies. 91 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. · 3 events, 3 records
  2. Philips Medical Systems North America Co. Phillips · 2 events, 9 records
  3. Philips Medical Systems (Cleveland) Inc · 2 events, 3 records
  4. Intuitive Surgical, Inc. · 2 events, 2 records
  5. Encore Medical, Lp · 1 event, 15 records
  6. Davol, Inc., Sub. C. R. Bard, Inc. · 1 event, 8 records
  7. GE OEC Medical Systems, Inc · 1 event, 8 records
  8. K Tek · 1 event, 7 records

FDA root cause

  1. Other · 74
  2. Device Design · 8
  3. Software design · 2
  4. Process control · 2
  5. Process change control · 1
  6. Packaging process control · 1
  7. Labeling mix-ups · 1
  8. Error in labeling · 1

Not yet classified (91)

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.