| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00985-1 |
| Product Name/Description |
Muliple Zimmer Highly Polished Implants (packaged in a Low Density Polyethylene (LDPE) Bag)
All lots manufactured prior to 1 April 2013
Multiple products affected
Multiple Part Numbers affected
ARTG Numbers: 95692, 208688, 99906, 95760, 115909 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
Residue or pieces of film from the LDPE bag containing the implant may adhere to the highly polished implant surface. The frequency of this occurrence is approximately 1 in 8000 cases. In a small number of these cases the affected device was implanted. Testing and analysis were conducted to evaluate potential risks such as abrasive wear, mechanical integrity and biocompatibility. These evaluations concluded that it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant because:
-The LDPE material is biocompatible, similar to the ultra high molecular weight polyethylene (UHMWPE).
-LDPE is softer than the two mating material of UHMWPE & cobalt chrome molybdenum. Therefore, is not expected to scratch either wear surface, which could increase wear rates and lead to osteolysis.
-If there were wear particulates generated from the LDPE bag, they would be expected to elicit similar reactions as those from UHMWPE. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer is advising users to examine potentially affected implants prior to use. Should a user encounter adhesion of a LDPE bag to a implant during surgery, it is recommended that the implant not be used. The implant can be returned to a Zimmer sales representative. |
| Contact Information |
1800 803 263 - Zimmer Customer Service |