Z-0918-2008

Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 8x102. Catalog Number...

Name: Z-0918-2008 Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 8x102. Catalog Number...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2007-11-15
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-11-15 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 8x102. Catalog Number 6485-3-308; Stryker Orthopaedics Mahwah, NJ 07430 on 2007-11-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0918-2008
Status: Terminated
Initiated: 2007-11-15
Posted: 2008-02-26
Terminated: 2008-09-22
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 8x102. Catalog Number 6485-3-308; Stryker Orthopaedics Mahwah, NJ 07430
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 803 total, all sizes
Distribution: Nationwide Distribution
Product codes and lots: Catalog Number 6485-3-308; Lot Codes: LCDBP;TEC024A;TEC024B;TEC080A;TEC080C.

Product code JDI

K952970Class IIHowmedica Femoral & Proximal Tibial Modular Replacement SytesmHowmedica Corp. / cleared 1996-01-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)