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Medical device recalls: December 2016

The FDA posted 71 medical device recall records in December 2016, from 45 recall events by 38 companies. 2 are Class I, the most serious category.

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. Amendia, Inc · 3 events, 4 records
  2. PerkinElmer Health Sciences, Inc. · 3 events, 3 records
  3. Accuray Incorporated · 2 events, 2 records
  4. Medtronic Inc · 2 events, 2 records
  5. Synthes (USA) Products LLC · 2 events, 2 records
  6. Sterling Diagnostics, Inc. · 1 event, 9 records
  7. MicroPort Orthopedics Inc. · 1 event, 7 records
  8. Stryker Instruments Div. of Stryker Corporation · 1 event, 7 records

FDA root cause

  1. Device Design · 12
  2. Process change control · 11
  3. Process control · 9
  4. Storage · 7
  5. Packaging · 5
  6. Under Investigation by firm · 4
  7. Software design · 4
  8. Other · 3

Class I recalls (2)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

Class II recalls (49)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Class III recalls (20)

Using the device is not likely to cause health problems, but it violates FDA rules.

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.