| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00260-1 |
| Product Name/Description |
NexGen CR-Flex Femoral Component, Porous, Size E, Right
Item number: 00-5952-015-02
Lot numbers: 64138317, 64275541
ARTG: 214320 - not on the register (cancelled) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet is conducting a lot specific implant hazard alert for the NexGen CR-Flex Femoral Component, Size E (00-5952-015-02).
This hazard alert is due to an out of specification violation that was observed in samples for the tensile feature during process monitoring. The investigation determined the root cause to be isolated and limited to manufacturing process for the NexGen CR-Flex Size E Femoral Components, where a gap could exist within the fixture that presses the fibre metal pad to the substrate. This gap may potentially cause the pad to not fully bond to the substrate, leading to the tensile specification failure. This in turn may lead to implant loosening and may require surgical intervention.
There have been no complaints related to the problem description reported. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
There are no specific patient monitoring instructions related to this hazard alert that are recommended beyond the surgeon’s existing follow-up schedule. If necessary, routine radiographic follow-ups can be completed to review the cementless in-growth at the interface at the anterior flange location. |
| Contact Information |
0427 939 358 - Aaron Rouse |