| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00554-1 |
| Product Name/Description |
Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants)
rHead Recon Stem Implant non-coated:
Size 1 Item: RCNS160, Lot: 19804S2
Size 2 Item: RCNS260, Lot: 19773-S2
Size 3 Item: RCNS360, Lot: 19807S2
Bipolar stem implant #1 Item RCNS1, Lot 19716S2
Bipolar stem implant #3 Item RCNS3, Lot19720-S2
Bipolar stem implant #4 Item RCNS4, Lot19816-S2
Radial stem implant #1 Item RHAS1, Lot19778S2
Radial stem implant #4 Item RHAS4, Lot19814-S2 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential that the packaging integrity (sterile barrier) of the packaging type KIT I may be compromised by transportation. A compromised sterile barrier could result in the surgeon selecting a back-up device or, if not recognised, an unintended implantation of a potentially non sterile device. The packaging type KIT I consists of a white cardboard box, an outer peel pouch, and an inner peel pouch
|
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is notifying hospitals and surgeons of the issue and recovering stock supplied to hospitals. Surgeons are advised of the potential hazards involved in the implantation of devices where the sterile barrier has been breached. This action has been closed-out on 18/08/2016. |
| Contact Information |
1800 803 601 - RAQA Coordinator |