Class II — Potential Health Hazard

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

DePuy Synthes Radiolucent Retractor Recalled by Synthes, Inc. Due to Particle residue on the instrument from adhesive tape...

Date: October 2, 2014
Company: Synthes, Inc.
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, Inc. directly.

Affected Products

DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715

Quantity: 11

Why Was This Recalled?

Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.

Where Was This Sold?

This product was distributed to 7 states: MI, NY, NC, PA, TN, WA, WI

Affected (7 states)Not affected

About Synthes, Inc.

Synthes, Inc. has 43 total recalls tracked by RecallDetector.

Related Recalls

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