Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both t...

FDA Device Recall #Z-0483-2014 — Class II — October 1, 2013

Recall Summary

Recall Number Z-0483-2014
Classification Class II — Moderate risk
Date Initiated October 1, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Howmedica Osteonics Corp.
Location Mahwah, NJ
Product Type Devices
Quantity Catalog Number 2030-6525-1- 4 units; Catalog No: 2029-5540-1-7 units

Product Description

Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA), when implanting Stryker's Hemispherical Cluster Hole Acetabular Shell Systems and Total Knee Arthroplasty (TKA) when implanting Stryker's Series 7000 Standard Tibial Tray systems. The use of bone screws, during both THA and TKA are intended as supplemental fixation.

Reason for Recall

Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm.

Distribution Pattern

Nationwide Distribution

Lot / Code Information

1) 6.5 mm Cancellous Bone Screw 25mm Catalog No: 2030-6525-1 Lot code MMLNLA 2) 5.5 Cancellous Bone Screw 40 mm Catalog No: 2029-5540-1 Lot Code MMLMJ1

Other Recalls from Stryker Howmedica Osteonics Corp.

Recall # Classification Product Date
Z-2160-2017 Class II Hoffmann LRF Safety Clip (Bone Transport Strut)... Apr 26, 2017
Z-1020-2017 Class II Reunion TSA Peg Alignment Sound Catalog #5901... Dec 2, 2016
Z-0880-2017 Class II GAM Kirschner Wire, Sterile R, T2 K-Wire, Steri... Nov 9, 2016
Z-0378-2017 Class II LFIT Anatomic V40 Femoral Head, Low Friction Io... Aug 29, 2016
Z-0060-2017 Class II Stryker Orthopaedics Universal Acetabular Cup P... Aug 18, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.