Integra UCR 3mm Hex, Large Axial Driver recallZ-1841-2014 · SeaSpine Inc · initiated May 21, 2014

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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. : .

Recall details

Recall number

Z-1841-2014

Recall class

Class II

Status

Terminated

Initiated by the company

May 21, 2014

Posted by the FDA

Jun 20, 2014

Recalling firm

SeaSpine Inc

Quantity

7

Product code

NKB

FDA submissions

K043232

Distribution

US Distribution including the states of : AL, CA, OH, NM and TN.

Product description

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.

Other devices under the same FDA submission

2 devices cleared under K043232 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• UCR 10-1045

  Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  3 reports
• UCR 10-1060

  Seaspine Orthopedics Corporation · ORTHOSIS, SPINAL PEDICLE FIXATION
  2 reports