Recall Z-1236-2008 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Stryker Howmedica Osteonics Corp.
Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307 to 5351-4317. For use as a Shoulder Replacement. Stryker Orthopaedics Made in USA
| Date | Jun 26, 2008 (initiated Nov 15, 2007) |
| Status | Terminated |
| Reason | Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units. |
| Root cause | Process control |
| Action | On 11/28/2007, Stryker Orthopaedics sent, via FedEx, Urgent Product Recall notification letters to distributors, hospitals, surgeons and hospitals' Chiefs of Orthopaedics informing them of the firm's voluntary recall of the affected product. They were instructed to discontinue use of the product and to have the units returned to the firm. Distributors were further instructed to notify their customers using the sub-recall letter provided by the firm. The letter to surgeons also informed them to monitor their patients who had received an implant of the product. |
| Quantity | 915 units |
| Distribution | Nationwide - USA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061677 | SOLAR PUREFIX HA SHOULDER Howmedica Osteonics Corp., Jul 10, 2006 |