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Medical device recalls: August 2010

The FDA posted 238 medical device recall records in August 2010, from 95 recall events by 72 companies. 238 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. · 4 events, 8 records
  2. Stryker Howmedica Osteonics Corp. · 4 events, 4 records
  3. Philips Healthcare Inc. · 3 events, 7 records
  4. Ge Healthcare, Llc · 3 events, 3 records
  5. Boston Scientific Corporation · 2 events, 36 records
  6. Linvatec Corp. dba ConMed Linvatec · 2 events, 19 records
  7. Biomet, Inc. · 2 events, 6 records
  8. Hill-Rom, Inc. · 2 events, 6 records

FDA root cause

  1. Packaging · 31
  2. Process design · 27
  3. Process control · 24
  4. Device Design · 23
  5. Nonconforming Material/Component · 21
  6. Material/Component Contamination · 18
  7. Packaging process control · 17
  8. Component design/selection · 17

Not yet classified (238)

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.