Recall of Grafton Demineralised Bone Matrix

Retail-level recall of 13 types of Grafton bone graft products due to issue with sterile barrier seal

Date of recall:

9 Feb 2023

Product:

T41120INT 1CC GRAFTON DBM GEL

T42275INT 8MMX1CMX10CM 2 EA GRAFTON DBM MATRIX

T42280INT 8MMX1CMX20CM 2 EA GRAFTON DBM MATRIX

T43101INT 0.5CC GRAFTON DBM PUTTY

T43102INT 1CC GRAFTON DBM PUTTY

T43103INT 2.5CC GRAFTON DBM PUTTY

T43105INT 5CC GRAFTON DBM PUTTY

T43110INT 10CC GRAFTON DBM PUTTY

T44125INT 5CC ORTHOBLEND LARGE DEF GRAFTON DBM

T44145INT 5CC ORTHOBLEND SMALL DEF GRAFTON DBM

T45001INT 1CC PASTE GRAFTON PLUS DBM

T45005INT 5CC PASTE GRAFTON PLUS DBM

T50106INT GRAFTON DBM DBF 6CC

Active Ingredient:

NA

Product Category:

Cell Tissue and Gene Therapy Products

Batch No.:

Please refer to attached PDF

Grafton Recall Batches159 KB

Class of Recall:

Class 1

Level of Recall:

Retail

Local Company:

Medtronic International Limited
https://www.medtronic.com/graftonrecall

Description of Issue:

Non-conforming packaging may lead to a breach in the sterile barrier.

Recall Instructions:

Hospitals, clinics, pharmacies

Stop supplying the affected batches and return the remaining stocks to the company.

Note:

Class of recall

A recall is classified as Class 1 or Class 2 depending on the potential hazard of the issue.

  • Class 1: For recalls of products with issues that can potentially cause serious adverse health outcomes or death.
  • Class 2: For recalls of products with issues that would not likely cause serious adverse health outcomes.

 

Level of recall

The level of product recall will depend on the potential hazard of the affected product, extent of distribution and whether other mitigating measures can be taken to address the issue.

  1. Consumer level: Affected product or batch(es) recalled from patients and consumers as well as wholesale suppliers, retail suppliers, hospitals, clinics and pharmacies.
  2. Retail level: Affected product or batch(es) recalled from retail suppliers, hospitals, clinics and pharmacies as well as wholesale suppliers.
  3. Wholesale level: Affected product or batch(es) recalled from wholesale suppliers.

 

Healthcare professional, Cell, Tissue and Gene Therapy Products
Published:

Product Recalls