Distal Centralizer 10 mm recallZ-0315-2011 · Ortho Development Corporation · initiated Jul 28, 2010
Terminated All recalls posted in November 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho Development Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0315-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 28, 2010
- Posted by the FDA
- Nov 3, 2010
- Recalling firm
- Ortho Development Corporation
- Quantity
- 39 units
- Product code
- KWY
- FDA submissions
- K962448
- Distribution
- Worldwide Distribution: Japan
Product description
Distal Centralizer 10 mm
Code information (models, lots, serial numbers)
Work order numbers: 0050794; 0051535; 0054967; 0055667; 0060372; 0061102; 0061769; 0062929; 0063395
Other devices under the same FDA submission
1 device cleared under K962448 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Encompass Hip Stem 114-2010Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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