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Medical device recalls: February 2010

The FDA posted 90 medical device recall records in February 2010, from 41 recall events by 32 companies. 90 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. · 5 events, 15 records
  2. Abbott Point of Care Inc. · 3 events, 4 records
  3. Stryker Spine · 2 events, 5 records
  4. Remel, Inc · 2 events, 3 records
  5. Siemens Healthcare Diagnostics, Inc. · 2 events, 2 records
  6. Becton Dickinson Medical Systems · 1 event, 19 records
  7. Merit Medical Systems, Inc. · 1 event, 6 records
  8. Cybernet Systems Corp. · 1 event, 4 records

FDA root cause

  1. Process control · 30
  2. Other · 9
  3. Component change control · 8
  4. Packaging · 6
  5. Nonconforming Material/Component · 6
  6. Component design/selection · 6
  7. Package design/selection · 4
  8. Software design · 3

Not yet classified (90)

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.