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Instructions For Use document of the GPS Trackers.

FDA Device Recall #Z-0288-2021 — Class II — September 10, 2020

Recall Summary

Recall Number Z-0288-2021
Classification Class II — Moderate risk
Date Initiated September 10, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Blue Ortho
Location Gieres, N/A
Product Type Devices
Quantity 3471 units

Product Description

Instructions For Use document of the GPS Trackers.

Reason for Recall

Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.

Distribution Pattern

Domestic Distribution Only: CA, CO, SC and WI.

Lot / Code Information

Model number: A100003 (Probe) Serial numbers for model A100003: 02-0200-17, 01-0034-19, 02-0097-19, 06-0160-19, 06-0168-19, 11-0083-18, 01-0072-19, 01-0216-14, 02-0091-19, 02-0195-17, 12-0040-15, 02-0192-17, 02-0199-17, 10-0021-12, 08-0028-19, 02-0104-19, 08-0017-19, 05-0380-19, 05-0371-19, 08-0026-19, 08-0003-19, 05-0362-19, 02-0061-19, 08-0064-12, 05-0381-19, 02-0079-19, 02-0050-17, 01-0205-14, 05-0068-18, 04-0288-19, 02-0067-17, 02-0031-17, 02-0064-17, 10-0009-12, 07-0018-14, 02-0008-18, 02-0060-17, 01-0129-19, 02-0044-17, 04-0293-19, 05-0031-14, 05-0365-19, 06-0192-19, 08-0036-18, 10-0024-17, 10-0030-12, 12-0049-19, 12-0050-19, 12-0059-19, 12-0061-19, 06-0221-19, 02-0090-19, 02-0108-19, 06-0187-19, 06-0161-19, 04-0301-19, 01-0120-19. Model number: A100005 (Diamond T) Serial numbers for model A100005: 08-0080-16, 09-0032-16, 04-0108-13, 08-0088-16, 09-0028-16, 05-0223-13, 12-0123-18, 06-0041-19, 04-0085-19, 06-0438-18, 01-0232-19, 02-0176-19, 05-0185-14, 09-0022-16, 01-0223-19, 04-0167-16, 06-0564-12, 02-0170-19, 05-0057-14, 11-0100-13, 09-0025-16, 02-0120-17, 04-0119-13, 09-0026-16, 10-0085-12, 09-0020-16, 12-0101-18, 11-0074-19, 10-0079-12, 07-0040-19, 10-0167-19, 03-0048-19, 05-0191-14, 10-0082-12, 07-0251-14, 06-0109-17, 10-0175-19, 10-0040-19, 01-0222-19. Model number: A100006 (Diamond G) Serial numbers for model A100006: 08-0106-16, 08-0093-16, 01-0342-14, 08-0105-16, 08-0107-16, 09-0136-18, 12-0187-18, 05-0137-19, 04-0185-19, 06-0489-18, 05-0129-19, 06-0064-19, 02-0214-19, 06-0168-17, 11-0087-16, 07-0488-19, 05-0077-16, 02-0218-19, 06-0159-17, 01-0288-19, 02-0180-17, 06-0153-17, 05-0386-14, 03-0375-14, 06-0167-17, 06-0130-17, 11-0098-16, 02-0164-17, 05-0396-14, 06-0143-17, 07-0350-19, 10-0225-19, 03-0120-19, 07-0108-17, 01-0341-14, 10-0237-19, 07-0083-17, 10-0232-19, 05-0066-16. Model number: A100004 (Diamond F) Serial numbers for model A100004: 04-0013-19, 03-0336-14, 03-0083-14, 01-0014-15, 05-0066-19, 05-0154-14, 01-0200-19, 01-0203-19.

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

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.

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