🔍 RecallPedia

Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591

Class I - Dangerous
🏥 Medical Devices Recalled: May 12, 2020 XTANT Medical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    LOT: XS1920458A
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
XTANT Medical
Reason for Recall:
The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591

Product Codes/Lot Numbers:

LOT: XS1920458A

Distribution:

Distributed in: AZ, TX, WV

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2500-2020

Related Recalls

XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI Number: M697X0980107STR1 Mat.: CP Ti Grade 4, Ref: X098-0108-STR DI Number: M697X0980108STR1 Mat.: CP Ti Grade 5, Ref: X098-0109-STR DI Number: M697X0980109STR1 Mat.: CP Ti Grade 6, Ref: X098-0110-STR DI Number: M697X0980110STR1 Mat.: CP Ti Grade 7, Ref: X098-0111-STR DI Number: M697X0980111STR1 Mat.: CP Ti Grade 8, Ref: X098-0112-STR DI Number: M697X0980112STR1 Mat.: CP Ti Grade 9, Ref: X098-0205-STR DI Number: M697X0980205STR1 Mat.: CP Ti Grade 10, Ref: X098-0206-STR DI Number: M697X0980206STR1 Mat.: CP Ti Grade 11, Ref: X098-0207-STR DI Number: M697X0980207STR1 Mat.: CP Ti Grade 12, Ref: X098-0208-STR DI Number: M697X0980208STR1 Mat.: CP Ti Grade 13, Ref: X098-0209-STR DI Number: M697X0980209STR1 Mat.: CP Ti Grade 14, Ref: X098-0210-STR DI Number: M697X0980210STR1 Mat.: CP Ti Grade 15, Ref: X098-0211-STR DI Number: M697X0980211STR1 Mat.: CP Ti Grade 16, Ref: X098-0212-STR DI Number: M697X0980212STR1 Mat.: CP Ti Grade 17, Ref: X098-0305-STR DI Number: M697X0980305STR1 Mat.: CP Ti Grade 18, Ref: X098-0306-STR DI Number: M697X0980306STR1 Mat.: CP Ti Grade 19, Ref: X098-0307-STR DI Number: M697X0980307STR1 Mat.: CP Ti Grade 20, Ref: X098-0308-STR DI Number: M697X0980308STR1 Mat.: CP Ti Grade 21, Ref: X098-0309-STR DI Number: M697X0980309STR1 Mat.: CP Ti Grade 22, Ref: X098-0310-STR DI Number: M697X0980310STR1 Mat.: CP Ti Grade 23, Ref: X098-0311-STR DI Number: M697X0980311STR1 Mat.: CP Ti Grade 24, Ref: X098-0312-STR DI Number: M697X0980312STR1 Mat.: CP Ti Grade 25

XTANT Medical

Class I - Dangerous

Cervical Implants contain a label that incorrectly identifies the grade of titanium used.

Sep 30, 2020 Other Medical Devices View Details →

OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect DBM Putty can be used as follows: - Extremities - Posterolateral spine - Pelvis.

XTANT MEDICAL

Class I - Dangerous

The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.

May 3, 2019 Surgical Instruments Nationwide View Details →