Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Titanium, Alloy and Hydroxyapatit
FDA device recall Z-1102-2010 · posted 2010-03-11 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The Restoration Modular Hip Stem may have two different package labels. The 14 mm diameter stem may be labeled with both a size 14 mm diameter and a 26 mm diameter.
- Action taken
- Stryker Branches were notified by e-mail on December 30, 2009. This was followed by a formal recall letter by Fed Ex sent on 1/11/10 to branches as well as the hospital and surgeon that used the device.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 1
- Distribution
- 1 device distributed to a hospital in GA.
- Date initiated
- 2009-12-30
- Date posted
- 2010-03-11
- Date terminated
- 2012-09-14
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 2 PIECE MODULAR HIP STEM (K013106) | Howmedica Osteonics Corp. | 2002-04-03 |