Z-0288-2021Class II

Instructions For Use document of the GPS Trackers

Name: Z-0288-2021 Instructions For Use document of the GPS Trackers
Creator: Blue Ortho
Published: 2020-09-10
License: https://open.fda.gov/license/

Blue Ortho / initiated 2020-09-10 / Terminated / root cause: sterility

FDA source

Blue Ortho began a recall of Instructions For Use document of the GPS Trackers on 2020-09-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0288-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-10
Posted: 2020-10-23
Terminated: 2023-05-31
Recalling firm: Blue Ortho
Product: Instructions For Use document of the GPS Trackers.
Product code: OLO Orthopedic Stereotaxic Instrument
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.
Root cause tag: sterility
FDA root cause: Other
Action: On 9/10/2020 the firm sent an Urgent Field Safety Notification to its consignees US FDA expressed concern with the 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, leveraged from proper validation files. Based on this concern, Blue Ortho decided to revise the appropriateness of the language used in the Tracker reprocessing instruction LEFUS Tracker for Low Temperature Sterilization v1.0 to remove such conditions. Blue Ortho has already updated the GPS Trackers IFUs, to remove the sterilizations cycle based on rational and not effectively supported by validation. The new version of the IFU is LEFUS Tracker for Low Temperature Sterilization v1.2 (version 1.1 has not been released to the field). The LEFUS Tracker for Low Temperature Sterilization v1.2 is enclosed to this notice. Transmission of this Field Safety Notice: " This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices or documents have been transferred. " Please transfer this notice to other organizations on which this action has an impact. " Please maintain awareness on this notice.
Quantity in commerce: 3471 units
Distribution: Domestic Distribution Only: CA, CO, SC and WI.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0288-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0288-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-23

Product code OLO

K193618Class IIExactechGPS SystemBlue Ortho / cleared 2020-09-02

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)