The Recall Desk
ModerateFDA (Devices)·Z-2464-2015·Announced 2015-09-02

Trilliant Surgical Recalls Tiger Cannulated Screw System Tray Lids

Trilliant Surgical Ltd. is recalling 71 units of Tiger Cannulated Tray Lids because they are occasionally difficult to remove from sterilization trays.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical difficulty in removing tray lids rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity recall.

Plain-English summary

Trilliant Surgical Ltd. is recalling 71 units of Tiger Cannulated Tray Lids (Part # 210-00-001-1) and Combined Tiger/Headless Screws (Part # 210-99-101). These non-sterile components are part of the Tiger Cannulated Screw System and Tiger Headless Cannulated Screw System, which are intended for the fixation of fractures, non-unions, arthrodesis, and osteotomies of the small bones in the hand and foot.

The recall was initiated because the sterilization tray lids were reported to occasionally be difficult to remove from the sterilization tray. The affected units are identified by Lot Numbers ALU120514552473 and 45479. The products were distributed nationwide.

Healthcare facilities and consumers should stop using these specific components and contact Trilliant Surgical Ltd. for further instructions or a replacement.

The recalled product

Product
Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tig
Affected units
71

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers ALU120514552473 and 45479

Distribution

Distributed nationwide across the United States.