Agency classClass IIOur severity:High FDA (Devices)·Z-1087-2019·Announced 2019-04-10

Zimmer Biomet Recalls RingLoc Hip System Self-Tapping Bone Screws

Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws due to a potential packaging error where 30mm screws may be labeled as 20mm and vice versa.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 high-risk medical device (orthopedic implant) where a packaging error could lead to the use of an incorrect screw length, posing a risk of harm, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Zimmer Biomet, Inc. is recalling 809 units of the Biomet RingLoc Hip System Self-Tapping Bone Screw, 6.5mm x 30mm-Low Profile Titanium (Item Number 103533). The recall is due to a potential packaging error where the 30mm screws may have been packaged as 20mm screws, and vice versa.

The affected products were distributed worldwide, including in the United States, Chile, China, Costa Rica, Gujarat (India), Japan, Mexico (CDMX), and Singapore. The recall involves specific lot numbers: 859960, 859980, 860120, 860310, and 860580.

Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected screws. Consumers who have had these implants should contact their healthcare provider for guidance.

The recalled product

Product: 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
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
incorrect-size
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 →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · mis labeling