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Medical device recalls: March 2008

The FDA posted 172 medical device recall records in March 2008, from 39 recall events by 37 companies. 172 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. · 2 events, 37 records
  2. Biomet 3i, Inc. · 2 events, 2 records
  3. Smith & Nephew, Inc. Endoscopy Division · 1 event, 24 records
  4. Smith And Nephew, Inc. Wound Management Division · 1 event, 19 records
  5. Medtronic Neuromodulation · 1 event, 13 records
  6. Zimmer Orthopaedic Surgical Products · 1 event, 10 records
  7. Pointe Scientific, Inc. · 1 event, 8 records
  8. Siemens Medical Solutions USA, Inc · 1 event, 8 records

FDA root cause

  1. Process control · 42
  2. Device Design · 37
  3. Nonconforming Material/Component · 35
  4. Other · 21
  5. Package design/selection · 19
  6. Process design · 5
  7. Software design · 4
  8. Labeling Change Control · 4

Not yet classified (172)

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.