Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Norian Drillable Inject 5 CC-Sterile Recalled by Synthes (USA) Products LLC Due to DePuy Synthes is initiating a voluntary medical device...

Date: May 11, 2016
Company: Synthes (USA) Products LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Synthes (USA) Products LLC directly.

Affected Products

Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.

Quantity: 2812 units

Why Was This Recalled?

DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Synthes (USA) Products LLC

Synthes (USA) Products LLC has 162 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report