Zimmer Biomet, Inc.: Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant

Is my product affected?

Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant

• UPC 00880304001961

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Biomet, Inc. recalled 809 units of 6.5mm RingLoc Hip System Self-Tapping Bone Screws, which are accessories used in total hip implant procedures. The recall was initiated because 30mm screws may have been packaged as 20mm screws and vice versa, creating a potential hazard if the incorrect length screw was implanted. The affected products were distributed worldwide, including throughout the United States and internationally to Chile, China, Costa Rica, India, Japan, Mexico, and Singapore.

The recall affects specific lot numbers identified as 523430, 523450, 860840, 860850, and 860860. The source document does not specify a remedy or instructions for affected consumers to follow.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.

Details from the source

Reason for recall: Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa. Distribution: Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE Quantity: 809 total Lot/code info: Lot Numbers/UDI Number 523430 (01) 00880304001961 (17) 280804 (10) 523430 523450 (01) 00880304001961 (17) 280727 (10) 523450 860840 (01) 00880304001961 (17) 280806 (10) 860840 860850 (01) 00880304001961 (17) 280809 (10) 860850 860860 (01) 00880304001961 (17) 280806 (10) 860860

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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