| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00093-1 |
| Product Name/Description |
VA-LCP Clavicle Plate 2.7, shaft, CS1, right
Product code: 02.112.621S
Lot number: 1201P12
ARTG: 157069
(Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Orthopaedic fixation plate, non-biodegradable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
The affected VA-LCP Clavicle Plate Shaft is being recalled as sterility cannot be confirmed for lot 1201P12.
While manufacturing conditions of the subject devices are maintained to reduce contamination, their use may result in infection. To date, Johnson & Johnson Pty. Ltd. (JJM) have not received any complaints related to infection for the subject products. |
| Recall Action |
Recall |
| Recall Action Instructions |
Implant Hazard Alert:
Health care providers who have implanted the subject products should consider the increased infection risk in their follow-up of patients who have received the affected implant, in addition to their usual standard of care for those procedures.
Medical Device Recall:
Surgeons and facilities are instructed to:
- Immediately inspect the device(s) in ivnentory to determine if they have affected product. If lot 1201P12 is found, quarantine this product and contact JJM for an immediate return.
Return any affected product as soon as possible, but within 30 business days, by contacting JJM Customer Service. |
| Contact Information |
1800 252 194 - JJM Customer Service |