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U.S. Department of Health and Human Services

Class 2 Device Recall Curve Navigation System

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  Class 2 Device Recall Curve Navigation System see related information
Date Initiated by Firm July 16, 2020
Create Date August 13, 2020
Recall Status1 Terminated 3 on July 27, 2021
Recall Number Z-2792-2020
Recall Event ID 86046
510(K)Number K183605  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product BRAINLAB Curve;
Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905
UDI (GTIN) for Curve: 04056481138011
Code Information CURVE 1.1 DUAL NAVIGATION STATION, Serial Numbers:  3911619001-19901, S/N of affected NDI Camera: P7-21527  1173019001-19901B, S/N of affected NDI Camera: P7-21173  1444519001-19901B, S/N of affected NDI Camera: P7-21183  1937319001-19901B, S/N of affected NDI Camera: P7-21325  2201419001-19901B, S/N of affected NDI Camera: P7-21324  2456219001-19901B, S/N of affected NDI Camera: P7-21382  3524219001-19901B, S/N of affected NDI Camera: P7-21414  5379420001-19901B, S/N of affected NDI Camera: P7-21830  5609520001-19901B, S/N of affected NDI Camera: P7-21892  6968320001-19901B, S/N of affected NDI Camera: P7-20390  4593720001-19901B, S/N of affected NDI Camera: P7-21655  7850820001-19901B, S/N of affected NDI Camera : P7-22083  6393920001-19901B, S/N of affected NDI Camera: P7-21895  3844314001-19901B, S/N of affected NDI Camera: P7-21449   CURVE DUAL DISPLAY NAVIGATION STATION, Serial Numbers:  0824912001-19900, S/N of affected NDI Camera: P7-21890  3894613001-19900, S/N of affected NDI Camera: P7-21780  4387415001-19900, S/N of affected NDI Camera:P7-07290  CURVE SINGLE DISPLAY NAVIGATION STATION, Serial Number: 5762713001-19905, S/N of affected NDI Camera: P7-10719 
Recalling Firm/
Manufacturer		 Brainlab AG
Olof-palme-str. 9
Munich Germany
Manufacturer Reason
for Recall		 Incorrect manufacturer calibration
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 18 units
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
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.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = Brainlab AG
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