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Class 2 Device Recall Instructions For Use document of the GPS Trackers. |
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Date Initiated by Firm |
September 10, 2020 |
Create Date |
October 23, 2020 |
Recall Status1 |
Terminated 3 on May 31, 2023 |
Recall Number |
Z-0288-2021 |
Recall Event ID |
86491 |
510(K)Number |
K193618
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Product Classification |
Orthopedic stereotaxic instrument - Product Code OLO
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Product |
Instructions For Use document of the GPS Trackers. |
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. |
Recalling Firm/ Manufacturer |
Blue Ortho 6 Allee De Bethleem Gieres France
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Manufacturer 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.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = OLO and Original Applicant = Blue Ortho
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