Stryker Howmedica Osteonics Corp. Stryker Modular Replacement System Curved Cemented Stem; MRS SM Curved Femoral Stem 10x102; Catalog Number: 6485-3-300; Stryker Orthopaedics Mahwah, NJ 07430 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker Modular Replacement System Curved Cemented Stem; MRS SM Curved Femoral Stem 10x102; Catalog Number: 6485-3-300; Stryker Orthopaedics Mahwah, NJ 07430
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Catalog Number: 6485-3-300, Lot Codes: TEC023A, TEC023B, TEC082.
Products Sold
Catalog Number: 6485-3-300; Lot Codes: TEC023A, TEC023B, TEC082.
Stryker Howmedica Osteonics Corp. is recalling Stryker Modular Replacement System Curved Cemented Stem; MRS SM Curved Femoral Stem 10x102; Catalog due to Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between tr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026