Class II — Potential Health Hazard

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

Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile. Recalled by Zimmer Biomet Spine, Inc Due to Zimmer Bioment Spine, Inc. announces a voluntary field...

Date: June 30, 2016
Company: Zimmer Biomet Spine, 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 Spine, Inc directly.

Affected Products

Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.

Quantity: 5

Why Was This Recalled?

Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zimmer Biomet Spine, Inc

Zimmer Biomet Spine, Inc has 3 total recalls tracked by RecallDetector.

Related Recalls

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