Zimmer Biomet, Inc.: Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant

Is my product affected?

Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant

• UPC 00880304008700

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

What happened

Zimmer Biomet, Inc. recalled 809 units of the Biomet RingLoc Hip System Self-Tapping Bone Screw (6.5mm x 30mm) worldwide due to a packaging error. The 30mm screws may have been packaged as 20mm screws, or vice versa, potentially affecting the proper installation of this accessory used in total hip implant procedures. The affected units were distributed across multiple countries including the United States, Chile, China, Costa Rica, India, Japan, Mexico, and Singapore, with specific lot numbers identified in the recall.

The source document does not specify a remedy for affected consumers.

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 units total Lot/code info: Lot Numbers/UDI Number 859960 (01) 00880304008700 (17) 280809 (10) 859960 859980 (01) 00880304008700 (17) 280805 (10) 859980 860120 (01) 00880304008700 (17) 280806 (10) 860120 860310 (01) 00880304008700 (17) 280823 (10) 860310 860580 (01) 00880304008700 (17) 280807 (10) 860580

Source

Official record: FDA (Device enforcement) ↗

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

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