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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 Stryker Australia Pty Ltd
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