Distal Centralizer 10 mm
This recall has been terminated (originally issued November 3, 2010).
- Company
- Ortho Development Corporation
- Recall Initiated
- July 28, 2010
- Posted
- November 3, 2010
- Terminated
- November 4, 2010
- Recall Number
- Z-0315-2011
- Quantity
- 39 units
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper.
Distribution
Worldwide Distribution: Japan
Lot / Code Info
Work order numbers: 0050794; 0051535; 0054967; 0055667; 0060372; 0061102; 0061769; 0062929; 0063395
Root Cause
Nonconforming Material/Component
Action Taken
Ortho Development sent a Field Notification Memo dated July 28, 2010 to Japan Medical Dynamic Marketing instructing them to reconcile parts that may have been used and return unused parts to Ortho. Customers can contact Ortho Development at 1-801-619-3419.
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