| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00193-1 |
| Product Name/Description |
Equinoxe Shoulder reverse total shoulder (rTSA) UHWMPE and anatomic total shoulder (aTSA) UHMWPE devices
Multiple batch and serial numbers
Multiple Product Codes
ARTG 264172, 264381, 270232, 278648, 279721, 293762 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) anatomic total shoulder (aTSA) and reverse total shoulder (rTSA) implants packaged in out-of-specification vacuum bags.
Oxidation can lead to faster device wear or failure, device component cracking or fracture, new or worsening pain, bone loss, and/or swelling in the affected area. Any of these outcomes could result in the need for revision surgery. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Recall:
Exactech has removed all affected products which were packaged in non-conforming bags and replaced them by NEW conforming stocks.
Implant Hazard Alert:
- Normal patient follow-up as per each surgeon’s standard of care is recommended. Surgeons should monitor patients who have implanted nonconforming product for potential device wear, failure, or bone loss and should consider performing X-rays to further evaluate the patient and their implanted device if a failed device is suspected.
- It is not recommended to remove well-functioning Equinoxe Shoulder Systems from patients who do not have any new or worsening pain or symptoms.
- Surgeons are encouraged to discuss revision surgery with patients who may have worsening pain or joint weakness that is potentially attributable to the device based on a clinical examination, on a case-by-case basis. As a part of shared decision-making, discuss the benefits and risks of all relevant treatment options with patients |
| Contact Information |
02 8882 9688 - Exactech Australia |