Stryker Osteosynthesis Reduction Spoon; 1 single unit to a package; non-sterile; Stryker Trauma GmbH, 2432 Schonkirchen,
FDA device recall Z-0191-2009 · posted 2008-10-28 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker has become aware of the potential for breakage of the Reduction Spoon designed prior to 2003.
- Action taken
- Recall notification letters were sent on August 14, 2008 to all branches and hospitals via Federal Express. Questions are to be directed to 201-831-5718 or a Trauma team member listed in the letter.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 1070 units
- Distribution
- Nationwide
- Date initiated
- 2008-08-14
- Date posted
- 2008-10-28
- Date terminated
- 2012-05-29
- Location
- Mahwah, NJ
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