| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01493-1 |
| Product Name/Description |
MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7
Item No: 180612; Lot No: 26080317-01
Item No: 180617; Lot No: 26150217-01
ARTG Number: 242173 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has discovered that the packaging of certain sizes and lots of the above-referenced product may contain the incorrect product and/or label. Two reports were received with the product/label discrepancy. In one report, the labelling of the implant box outer label stated Size 2 RM/LL, and the labelling of the implant sticker (Patient label) located inside the outer box state Size 7 RM/LL. The correct implant Size 2 RM/LL was inside the box. The patient label was incorrect in this report. The second report described that a size 2 implant was in a box labelled as a size 7 implant. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising users to quarantine affected stock immediately. Customers should contact their Stryker representative to arrange for return of affected product.
This action has been closed out on the 12/09/2018 |
| Contact Information |
02 9467 1175 - Stryker Australia |