FDAClass IIApril 10, 2019

Biomet RingLoc Hip System Self-Tapping Bone Screw recall

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

Why was Biomet RingLoc Hip System Self-Tapping Bone Screw recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage…
Recalling firm
Zimmer Biomet, Inc.
Quantity
809 units total
Distribution
Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE
Recall date
April 10, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls