Z-1841-2014Class II

Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant...

Name: Z-1841-2014 Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant...
Creator: SeaSpine Inc
Published: 2014-05-21
License: https://open.fda.gov/license/

Seaspine, Inc. / initiated 2014-05-21 / Terminated

FDA source

SeaSpine Inc began a recall of Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction... on 2014-05-21. FDA classified it as Class II and gives the reason as "Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1841-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-21
Posted: 2014-06-20
Terminated: 2014-12-15
Recalling firm: Seaspine, Inc.
Product: Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. Indications For Use: The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. The intended use of the Malibu, UCR, and NewPort Systems, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use.
FDA root cause: Under Investigation by firm
Action: Integra sent an Urgent Voluntary Medical Device Recall letter dated May 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. If you have distributed the affected product, identify those customers and forward the attached Integra Medical Device Recall Notice to them. 2. Inspect your inventory of UCR 3mm Hex, Large Axial Drivers (Catalogue Number: 91- 1123). If you have product with lot number MO16090B, STOP USING IMMEDIATELY. If you have product of any other lot number, you can continue to use it. The event has been isolated to this single lot. 3. We also request that regardless if you have a UCR Driver with the affected lot, you complete the attached form and return it to us as soon as possible as indicated. We recommend you keep a copy of the form for your records. 4. When your form is received, Customer Service will contact you and provide an RMA number, directions to return the product, and input an order to replace the quantity you indicate on the form. Should you have any questions regarding these instructions, please contact Customer Service at 1-866- 942-8698. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort. : .
Quantity in commerce: 7
Distribution: US Distribution including the states of : AL, CA, OH, NM and TN.
Product codes and lots: Catalogue Number: 91- 1123. Lot No. M016090B.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1841-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1841-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-20

Product code NKB

K043232Class IIUcr Spinal SystemSeaspine / cleared 2004-12-21

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)