—#67933

Product

Trident Hemispherical Solid BK Acetabular Shells; 42mm to 74mm, Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430

FDA product code: MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K013676
Affected lot / code info: Catalog number: 500-01-42A, 42 mm; 500-01-44B, 44 mm; 500-01-56C, 46mm; 500-01-48D, 48mm; 500-01-50D, 50mm; 500-01-52E, 52mm; 500-01-54D, 54mm; 500-01-56, 56mm; 500-01-58E, 58E; 500-01-60G, 60mm; 500-01-62G, 62mm; 500-01-64H, 64mm; 500-01-66H, 66mm; 500-01-68I, 68mm; 500-01-701, 70mm; 500-01-72J, 72mm; 500-01-74J, 74mm. All lot codes with an expiration date between January 2005 (2005-01) and December 2012 (2012-12)

Why it was recalled

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

Root cause (FDA determination)

Process design

Action the firm took

Recall notification letters were sent to Stryker Branches/agencies, OR Supervisors and Chief of Orthopaedics on 1/21/08. A Patient information sheet was sent on 2/4/08 to surgeons and hospitals. Per call with Center 2/4/08, recall letter to be revised and RES updated upon receipt. The letter was revised and sent on February 28, 2008 to include Trident PSL Acetabular shells. This letter was sent to Risk Management at hospitals and included the scope of the recall , the potential hazard and recommendation to physicians to monitor patients consistent with care for those receiving total hip replacement. It was also sent to surgeons and a revised letter to Stryker branches. A product acknowledgement form was included in all letters to indicate receipt of letter and quantity of product on hand, if applicable.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Nationwide distribution.

Timeline

Recall initiated: 2008-01-21
Posted by FDA: 2008-06-12
Terminated: 2012-09-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67933. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.