The Recall Desk
HighFDA (Devices)·Z-1086-2019·Announced 2019-04-10

Zimmer Biomet Recalls RingLoc Hip System Bone Screws Due to Packaging Error

Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws because 30mm screws may have been packaged as 20mm screws, and vice versa.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (incorrect screw length during surgery) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Zimmer Biomet, Inc. is recalling 809 units of the Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium (Item Number: 103531). The recall involves two lengths of the 6.5mm screw, specifically the 20mm and 30mm variants, which are accessories to total hip implants.

The recall was initiated because there is a potential for the 30mm screws to be packaged as 20mm screws and vice versa. This packaging error could result in the wrong length of screw being used during a surgical procedure.

The affected products were distributed worldwide, including in the United States, Chile, China, Costa Rica, Gujarat (India), Japan, Mexico (CDMX), and Singapore. The specific lot numbers involved are 523430, 523450, 860840, 860850, and 860860. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected screws.

The recalled product

Product
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
Affected units
809

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →