| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00979-1 |
| Product Name/Description |
Locking Screws Stardrive Ø 2.4 mm, Self-Tapping, Length 12 mm, Titanium-Alloy-Niobium Alloy (Orthopaedic bone screw)
Part Number: 412.812
Lot Numbers: 9744302, 9946065
Supplied as part of following systems:
LCP Distal Radius System 2.4
LCP Compact Hand 2.4
LCP Compact Foot 2.4
2.4/2.7 mm Locking Tarsal Plates
ARTG number: 157068 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
It was identified that the specified lots of the Locking Screws Stardrive Ø 2.4 mm, self-tapping, length 12 mm, TAN can break between the head and the shaft. This resulted from the neck feature being too close to the Stardrive feature leaving a thin wall between the neck and drive. In the event that the non-conforming screw should separate between the head and the shaft during insertion or removal, a surgical delay may occur as the surgeon attempts to remove the shaft or fragment from the bone. Removal of fragments can result in bone damage. Additionally, a protruding fragment can lead to adverse tissue reaction or soft tissue irritation. |
| Recall Action |
Recall |
| Recall Action Instructions |
Johnson &Johnson Medical (JJM) is advising customers to identify, quarantine and return all unpackaged Locking Screws Stardrive Ø 2.4 mm, self-tapping, length12 mm, TAN in kits along with any screws still in the original packaging with the affected part and lot number. JJM Customer Service will organise replacement products for the returned stock. This action has been closed-out on 07/09/2018. |
| Contact Information |
1300 562 711 – JJM Customer Service |