| TGA Action ID |
RC-2026-RN-00834-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
GrapplerR3FLEX Stabilization System Kits
Item Number: P82-001-1237-SK
Lot Numbers (Electronic): 6160918126, 6160817626
Lot Numbers (Label): 946160918126, 946160817626 |
| ARTG Number |
469490 |
| Unique Device Identifier (UDI) |
(01)00889795128140(17)310625(10)946160817626, (01)00889795128140(17)310630(10)946160918126 |
| Action Type |
Recall / Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Two lots of GrapplerR3FLEX Stabilization System Kits were manufactured without the pre-tied knot during the assembly process, which could potentially result in the anchor assembly not properly holding tension.
An affected unit may fail to provide proper fixation. This could result in a clinically significant extension of surgery, pain, instability and/or reduced ankle function, with or without further surgery.
One complaint has been received worldwide. No complaints of this problem have been received in Australia. No adverse event reports have been received. |
| Instructions for Customers/Users |
Customers are to:
- Immediately identify and quarantine all affected lots and stop use.
- Return affected stock to the sponsor.
If the product has been implanted, surgeons are to assess the patient with imaging and monitor for the potential risks to assess whether further intervention may be required. |
| Action Commencement Date |
21/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 002 028 - Zimmer Biomet Customer Service |