FDA Device

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

Hazard

Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units.

What You Should Do

Remedy

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.

Products

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
Brand
Stryker Howmedica Osteonics Corp.
UPC
All Lot Codes for the following: Catalog # 5351-4307, 7mm; 5351-4308, 8mm; 5351-4309, 9mm; 5351-4310, 10mm; 5351-4311, 11mm; 5351-4312, 12mm; 5351-4313, 13mm; 5351-4314, 14mm; 5351-4315, 15mm; 5351-4316, 16mm; and 5351-4317, 17mm.

Units Affected

915 units