Recall Z-0080-2008 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Stryker Howmedica Osteonics Corp.
ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm; Hydroxylapatite coated; Titanium Plasma Spray; Howmedica Osteonics Corp.
| Date | Nov 1, 2007 (initiated May 9, 2007) |
| Status | Terminated |
| Reason | The plasma spray may delaminate from the proximal portion of the humeral stem. |
| Root cause | Process control |
| Action | Market Withdrawal letters were sent on May 9, 2007 via Federal Express. Letters to implanting physicians will be mail on or about mailed November 1, 2007. Stryker is also reissuing original letters indicating that this action is a Recall and advising of possible health hazards. |
| Quantity | 232 units |
| Distribution | One hospital in Akron OH and 12 Stryker branches/agencies |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062113 | SOLAR REUNION FRACTURE STEM Howmedica Osteonics Corp., Oct 3, 2006 |