Femoral Condylar Plate and Nails (2013--11-08)

Starting date:

November 8, 2013

Posting date:

December 4, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-37007

• 
  Reason
• 
  Affected products

Recalled products

1. Periarticular - Femoral Condylar Plates
2. Neff Femorotibial Nail - Femoral Comp.
3. Neff Femorotibial Nail -Tibial with Screws

Reason

Zimmer has identified a packaging tray configuration that consists of an inner and outer sterile tray, where there may be cosmetic failures related to the visual quality of the seal (Homogeneous Adhesive Transfer). This failure has been observed on inner trays only. No physical failures in either peel strength or pressure testing have been observed.

Affected products