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Medical device recalls: December 2010

The FDA posted 258 medical device recall records in December 2010, from 93 recall events by 71 companies. 258 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. · 7 events, 33 records
  2. Bio-Rad Laboratories Inc · 4 events, 5 records
  3. Stryker Endoscopy · 3 events, 3 records
  4. Merit Medical Systems, Inc. · 2 events, 12 records
  5. Philips Medical Systems North America Co. Phillips · 2 events, 7 records
  6. Boston Scientific Corporation · 2 events, 5 records
  7. Encore Medical, Lp · 2 events, 5 records
  8. Baxter Healthcare Corp. · 2 events, 3 records

FDA root cause

  1. Other · 139
  2. Device Design · 36
  3. Process control · 12
  4. Nonconforming Material/Component · 12
  5. Material/Component Contamination · 10
  6. Process design · 9
  7. Pending · 8
  8. Packaging process control · 8

Not yet classified (258)

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.