Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows...
FDA Device Recall #Z-1976-2013 — Class I — May 30, 2013
Recall Summary
| Recall Number | Z-1976-2013 |
| Classification | Class I — Serious risk |
| Date Initiated | May 30, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Spine |
| Location | Allendale, NJ |
| Product Type | Devices |
| Quantity | 1536 units (US) 880 (Foreign) |
Product Description
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
Reason for Recall
Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
Distribution Pattern
Nationwide Distribution.
Lot / Code Information
K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above
Other Recalls from Stryker Spine
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1489-2025 | Class II | Monterey AL Implant Inserter; 14/16mm; Catalog ... | Feb 28, 2025 |
| Z-1490-2025 | Class II | Monterey AL Implant Inserter; 18/20mm; Catalog ... | Feb 28, 2025 |
| Z-1491-2025 | Class II | Monterey AL Implant Inserter; 22mm; Catalog 480... | Feb 28, 2025 |
| Z-1488-2025 | Class II | Monterey AL Implant Inserter; 10/12mm; Catalog ... | Feb 28, 2025 |
| Z-3210-2024 | Class II | AVS Anchor-C Cervical Cage System Instructions ... | Aug 23, 2024 |
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.