—#66556

Product

Stryker Modular Replacement System Curved Cemented Stem; MRS 15mmx203mm Femoral Stem. Catalog Number: 6485-3-315; Stryker Orthopaedics Mahwah, NJ 07430

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K952970
Affected lot / code info: Catalog Number: 6485-3-315; Lot codes: D6TEBR, D6TECR, LCDAT, TEC019A, TEC019A1, TEC019E, TEC132A, TEC133, TEC134, TEC135, TEC136.

Why it was recalled

Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.

Root cause (FDA determination)

Process design

Action the firm took

On November 26, 2007, Stryker Sent Urgent Product Recall notification letters to Stryker Agencies/Branches and hospitals (OR Supervisor) by Federal Express. The notification requested that all inventory be examined and returned. Returning instructions were provided in the letter. Questions concerning this recall are being addressed by contacting the Regulatory Compliance Hotline at (201) 831-6633.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2007-11-15
Posted by FDA: 2008-02-26
Terminated: 2008-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66556. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.