| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01305-1 |
| Product Name/Description |
Affinis Inverse inlay ceramys & Affinis Fracture ceramic heads (Total Shoulder System that is designed for treating shoulder conditions)
Affinis Inverse inlay ceramys
Item numbers: 62.34.0066, 62.34.0067, 62.34.0068, 62.34.0069, 62.34.0070 62.34.0071, 62.34.0072, 62.34.0073 & 62.34.0074
Affinis Fracture ceramic heads
Item numbers: 60.25.0042, 60.25.0045 & 60.25.0048
All Batch numbers
ARTG number: 215501 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Mathys Ltd Bettlach, received reports of disconnection of Affinis Inverse inlay ceramys and Affinis Fracture ceramic heads. Subsequent investigations have identified that the inlay and individual implant components complied with the defined specifications.
For Affinis Fracture ceramic heads:
The disconnections may have resulted from inadequate primary fixation due to insufficient head-cone connection or by protruding bone residue, cement residue or soft tissue fragments inside the cone connection.
For Affinis Inverse inlay ceramys:
The disconnection incident was caused by insufficient fixation of the inlay on the cone due to lack of impaction. The Affinis Inverse inlay ceramys has not been supplied in Australia.
To minimise occurrences of disconnection, additional instructions and notes regarding ceramic inlay implantation and ceramic head implantation have been added to the Surgical Technique and the Instructions for Use (IFU).
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Mathys Ltd Bettlach is requesting the customers to replace all Surgical Techniques and Instructions for Use (IFUs) for Affinis Inverse and/or Affinis Fracture with the updated versions provided. The sponsor has directly contacted the surgeon to notify of the implications of inadequate fixation and to provide the updated instructions.
Further information will be published on the TGA web site at http://www.tga.gov.au/current-year-alerts This action has been closed-out on 14/07/2016. |
| Contact Information |
02 9417 9200 - Mathys Orthpaedics |