| TGA Action ID |
RC-2026-RN-00510-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
The Hoffmann II Micro External Fixation System
Description: Connecting Rod Hoffmann II Micro Ø 3 x 30mm, Connecting Rod Hoffmann II Micro Ø 3 x 40mm, Connecting Rod Hoffmann II Micro Ø 3 x 50mm, Connecting Rod Hoffmann II Micro Ø 3 x 60mm, Connecting Rod Hoffmann II Micro Ø 3 x 90mm, Connecting Rod Hoffmann II Micro Ø 3 x 120mm,
Connecting Rod Hoffmann II Micro Ø 3 x 150mm
Catalogue Numbers: 50796030, 50796040, 50796050, 50796060, 50796090, 50796120, 50796150
All Lots |
| ARTG Number |
345574 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Subsequent to product complaints, Stryker has confirmed that cracking of the Hoffmann II Carbon Connecting Rods may occur following cleaning and sterilisation. Contrary to the original product labelling, the part is not suitable for reprocessing, and cleaning and sterilisation should not be performed, as this may result in cracks developing.
The hazard associated with this problem is insufficient rigid fixation causing loss of mechanical stability. In the event that cracks are detected intraoperatively, prolongation of surgery or change of surgical method may occur. In the event that cracks are present but not detected, a construct failure may occur which could necessitate a revision surgery to prevent permanent harm. |
| Instructions for Customers/Users |
Customers are to:
1. Inform individuals within the organisation that cleaning and sterilisation should not be performed, as this may result in cracks developing.
2. Inspect inventory for affected product by visually checking for signs of cracking.
a) If cracking is identified: Quarantine, all affected products will be returned via the complaint process.
b) If no cracking is observed: Continue normal care. Post-operative follow-ups should be maintained.
3. Complete and return the Response Form to Stryker.
Stryker is currently redesigning the affected product and will provide further communication once the redesigned parts have been implemented and replacement parts are available. |
| Action Commencement Date |
21/07/2026 |
| Responsible Entity |
|
| Contact Information |
postmarketssp@stryker.com - Stryker Quality and Post Market |