Z-2792-2020Class II

BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for...

Name: Z-2792-2020 BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for...
Creator: Brainlab AG
Published: 2020-07-16
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2020-07-16 / Terminated / root cause: manufacturing process

FDA source

Brainlab AG began a recall of BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011 on 2020-07-16. FDA classified it as Class II and gives the reason as "Incorrect manufacturer calibration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2792-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-16
Posted: 2020-08-13
Terminated: 2021-07-27
Recalling firm: Brainlab, Inc.
Product: BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Incorrect manufacturer calibration
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2792-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2792-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-13
Z-2793-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-13

Product code OLO

K183605Class IISpine & Trauma NavigationBrainlab AG / cleared 2019-08-29

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)