Z-1986-2019Class III

Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial...

Name: Z-1986-2019 Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial...
Creator: Clariance Inc
Published: 2019-07-01
License: https://open.fda.gov/license/

Clariance, Inc. / initiated 2019-07-01 / Terminated

FDA source

Clariance Inc began a recall of Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all... on 2019-07-01. FDA classified it as Class III and gives the reason as "Potential for the polyaxial screw to become disassembled during implant". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1986-2019
Classification: Class III
Status: Terminated
Initiated: 2019-07-01
Posted: 2019-07-18
Terminated: 2020-07-09
Recalling firm: Clariance, Inc.
Product: Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Potential for the polyaxial screw to become disassembled during implant.
FDA root cause: Use error
Action: Clariance, Inc. notified customers on about 07/01/2019 via "MEDICAL DEVICE FIELD SAFETY NOTICE - SN20190603". Customers were informed that when using the 18710024 Screwdriver, the user should ensure that the tip of the screwdriver is properly engaged into the receiving Torx bore of the Erisma-LP polyaxial screw. After proper engagement, the user is able to fully connect the screwdriver on the screw head. Disassembly of the polyaxial screw can occur when the 18710024 Screwdriver is not fully inserted and threaded into the screw head. Additionally when using the 18720000T20 Wrench or 01720001 T20 Snap Fit Tightening Wrench, the user should ensure that the tip of the T20 Wrench or the T20 Snap Fit Tightening Wrench is properly engaged into the receiving Torx bore of the Erisma-LP polyaxial screw. After proper engagement the user is able to adjust the insertion depth of the polyaxial screw. Customers were instructed to read the Field Safety Notice carefully, review the revised Surgical Techniques Guide provided as Attachment A that include in Section 2, Insertion of Pedicle Screws, enhanced instructions to help ensure that the user properly uses the 18710024 Screwdriver, the 18720000T20 Wrench, or the 01720001 T20 Snap Fit Tightening Wrench with the Erisma-LP polyaxial screws, in order to help reduce the possibility of disassembly. They were also instructed to replace the existing Surgical Techniques Guide(s) within your files with the revised Surgical Techniques Guide and to complete and return the response card, Attachment B. Questions can be directed to Clariance via telephone 773-868-7041, or your local sales representative.
Quantity in commerce: 4,090 units distributed in the US
Distribution: Nationwide distribution to CA, IL, IN, NY, OH, TX.
Product codes and lots: 1. Catalog Numbers: 181545XX, 181555XX, 181565XX, 181575XX, 181585XX, 181595XX, 181510XX; 2. Catalog Number 18710024; 3. Catalog Number 18720000; 4. Catalog Number 01720001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1986-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1986-2019	Class III	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-18

Product code NKB

K153326Class IIErisma-LP Spinal Fixation SystemClariance, Sas / cleared 2016-03-08

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)