Class II — Potential Health Hazard

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

ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The Recalled by Zimmer Biomet, Inc. Due to Zimmer Biomet is conducting a medical device recall...

Date: June 16, 2017
Company: Zimmer Biomet, 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 Zimmer Biomet, Inc. directly.

Affected Products

ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added to the top and bottom of the tray for protection. The inner tray and the contents within will then have a Tyvek¿ lid heat sealed to the tray. The sealed inner tray will be fit into an outer PETG tray and a Tyvek¿ lid heat sealed to the tray. The entire sealed unit is placed in a SBS carton that will be shrink wrapped for protection.

Why Was This Recalled?

Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem.

Where Was This Sold?

US, Canada, OUS.

About Zimmer Biomet, Inc.

Zimmer Biomet, Inc. has 875 total recalls tracked by RecallDetector.

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