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Medical device recalls: February 2009

The FDA posted 221 medical device recall records in February 2009, from 38 recall events by 34 companies. 221 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. Terumo Cardiovascular Systems Corporation · 2 events, 14 records
  2. Stryker Medical Div. of Stryker Corporation · 2 events, 7 records
  3. Zimmer Inc. · 2 events, 3 records
  4. GE Healthcare Integrated IT Solutions · 2 events, 2 records
  5. King Systems Corp. · 1 event, 142 records
  6. Cardiac Science Corporation · 1 event, 7 records
  7. Synthes Spine · 1 event, 6 records
  8. Advanced Bionics LLC · 1 event, 4 records

FDA root cause

  1. Pending · 142
  2. Device Design · 24
  3. Software design · 13
  4. Process control · 8
  5. Nonconforming Material/Component · 8
  6. Packaging process control · 6
  7. Other · 6
  8. Employee error · 4

Not yet classified (221)

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.