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Terminated

Stryker Modular Replacement System Curved Cemented Stem; MRS SM Curved Femoral Stem 10x102; Catalog Number: 6485-3-300; Stryker Orthopaedics Mahwah, NJ 07430

FDA Recall Z-0917-2008 · Posted 2008-02-26

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJDI
Date Initiated2007-11-15
Date Terminated2008-09-22
Product Quantity803 total, all sizes

Reason for Recall

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.

Firm Action

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.

Root Cause

Process design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952970HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESMHowmedica Corp. · 1996-01-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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