6376 M-1 Cot Fastener, catalog no. 6376000000
FDA Device Recall #Z-1598-2018 — Class II — March 9, 2018
Recall Summary
| Recall Number | Z-1598-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 9, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Medical Division of Stryker Corporation |
| Location | Portage, MI |
| Product Type | Devices |
| Quantity | 59 |
Product Description
6376 M-1 Cot Fastener, catalog no. 6376000000
Reason for Recall
The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
Distribution Pattern
Product distributed to the Netherlands
Lot / Code Information
Serial No. 170740300 170740301 170740302 170740303 170740304 170740305 170740306 170740307 170740308 170740309 170740310 170740311 170740312 170740313 170740314 170740315 170740316 170740317 170740318 170740319 170740320 170740321 170740322 170740323 170740324 170740325 170740326 170740327 170740328 170740329 170740330 170740331 170740332 170740333 170740334 170740335 170740336 170740337 170740338 170740339 170740340 170740341 170740342 170740343 170740344 170740345 170740346 170740347 170740348 170740349 170740350 170740351 170740352 170740353 170740354 170740355 170740356 170740357 170740358
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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.