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Class 2 Device Recall Kick Navigation System |
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Date Initiated by Firm |
July 16, 2020 |
Create Date |
August 13, 2020 |
Recall Status1 |
Terminated 3 on July 27, 2021 |
Recall Number |
Z-2793-2020 |
Recall Event ID |
86046 |
510(K)Number |
K183605
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Product Classification |
Orthopedic stereotaxic instrument - Product Code OLO
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Product |
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655 |
Code Information |
KICK 2 NAVIGATION STATION, Serial Numbers: 0164217001-18170, S/N of affected NDI Camera: P7-12520 2703119001-18170, S/N of affected NDI Camera:P7-20938 2933119001-18170, S/N of affected NDI Camera:P7-21378 6171619001-18170, S/N of affected NDI Camera:P7-18830 8745417001-18170, S/N of affected NDI Camera:P7-15162 9178819001-18170, S/N of affected NDI Camera:P7-16025 9607118001-18170, S/N of affected NDI Camera:P7-13227 5469918001-18170, S/N of affected NDI Camera: P7-14965 KICK NAVIGATION STATION, Serial Number: 1190017001-18070, S/N of affected NDI Camera: P7-06110 |
Recalling Firm/ Manufacturer |
Brainlab AG Olof-palme-str. 9 Munich Germany
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Manufacturer Reason for Recall |
Incorrect manufacturer calibration
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FDA Determined Cause 2 |
Process control |
Action |
1. Refer to the appendix for the list of Brainlab Curve or Kick Navigation Systems with an affected camera
installed to determine if your navigation system is affected.
2. For Cranial or ENT navigation software in combination with an affected system camera installed: Do
not use the Z-touch Laser Pointer for patient registration. Use other instruments with the standard
instrument pivoting method for Surface Matching or Landmark Registration, or Automatic Image Registration
(AIR) if available.
3. Please continue to follow the instructions and warnings as described in the user guide. Especially relevant is
the following warning, in addition to the instructions on the registration verification page appearing in the
Cranial or ENT software:
Verify accuracy at multiple anatomical landmarks, especially in the region of interest, as it
may differ from the accuracy verified on the skin surface. If the region of interest is not
accessible, verify in areas as close as possible to the region of interest.
4. In order to avoid nuisance with Spine & Trauma 3D or Orthopedic Navigation software in combination with an
affected system camera installed: Do not attempt to use the optional Disposable Clip-On Remote Control. For
patient registration, acquire registration points with the standard instrument pivoting method; or for Spine &
Trauma 3D use Automatic Image Registration (AIR) if available. |
Quantity in Commerce |
9 unit |
Distribution |
USA: CA, TX, RI
OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain |
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 = Brainlab AG
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