Recall Z-1102-2010 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Stryker Howmedica Osteonics Corp.
Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Titanium, Alloy and Hydroxyapatite. Catalog number: 6276-5-014.
| Date | Mar 11, 2010 (initiated Dec 30, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 1 |
| Distribution | 1 device distributed to a hospital in GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013106 | 2 PIECE MODULAR HIP STEM Howmedica Osteonics Corp., Apr 3, 2002 |