| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00115-1 |
| Product Name/Description |
Grays Osteotome Cup Cutting Tips
Description: Grays Osteotome Cup Cutting Tip 26 x140
Catalogue Number: 62105100
GTIN: 07613327144086
Description: Grays Osteotome Cup Cutting Tip 32 x 140
Catalogue Number: 62105200
GTIN: 07613327144093
Multiple Lot Numbers
ARTG 305260
(Stryker Australia Pty Ltd - Orthopaedic prosthesis implantation instrument, reusable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
Stryker is initiating a Recall of multiple batches of the Grays Osteotome Cutting Tips after discovering that they may puncture their inner and outer packaging or damage the packaging seals.
A potential harm of infection was identified due to contaminants such as bacteria, fungi, and viruses as well as transportation damage hazard sustained to the sterile packaging of the affected devices.
The presence of the protective end caps or the foam inserts on the product within the packaging assembly may mitigate the potential occurrence of a packaging breach. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
- Always inspect the packaging of all sterile products for flaws in their sterile barriers before opening. If a flaw is identified, the product must be considered nonsterile, as per IFU.
- Check their inventory for affected products (Appendix 1: Affected Items & Lots) and safely dispose of them.
- Contact a Stryker representative for the replacement of any affected products.
- If any serious injuries associated with these products has occurred, inform Stryker immediately. |
| Contact Information |
postmarketssp@stryker.com - Stryker Australia Pty Ltd |