Product Recalls
Recall of Grafton Demineralised Bone Matrix
Audiences
Healthcare professional
Product type
Cell, Tissue and Gene Therapy Products
9 February 2023
Retail-level recall of 13 types of Grafton bone graft products due to issue with sterile barrier seal
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Recall details
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 |
Class of Recall: | Class 1 |
Level of Recall: | Retail |
Local Company: | Medtronic International Limited |
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.
Consumer level: Affected product or batch(es) recalled from patients and consumers as well as wholesale suppliers, retail suppliers, hospitals, clinics and pharmacies.
Retail level: Affected product or batch(es) recalled from retail suppliers, hospitals, clinics and pharmacies as well as wholesale suppliers.
Wholesale level: Affected product or batch(es) recalled from wholesale suppliers.