Distal Centralizer 10 mm
FDA device recall Z-0315-2011 · posted 2010-11-03 · Terminated
Recall details
- Recalling firm
- Ortho Development Corporation
- Reason for recall
- The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KWY
- Quantity affected
- 39 units
- Distribution
- Worldwide Distribution: Japan
- Date initiated
- 2010-07-28
- Date posted
- 2010-11-03
- Date terminated
- 2010-11-04
- Location
- Draper, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMALOC CEMENTED HIP SYSTEM (K962448) | Ortho Development Corp. | 1996-09-19 |