Class II — Potential Health Hazard

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

Product 50 consists of all product under product code: JWH Recalled by Zimmer Manufacturing B.V. Due to As a result of the insufficient sealer calibration...

Date: January 11, 2016
Company: Zimmer Manufacturing B.V.
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 Manufacturing B.V. directly.

Affected Products

Product 50 consists of all product under product code: JWH and same usage: Item no: 595002701 NEXGEN MIS TIBIA PLATE PR 595002702 NEXGEN MIS TIBIA PLATE PR 595003701 NEXGEN MIS TIBIA PLATE PR 595003702 NEXGEN MIS TIBIA PLATE PR 595003712 NEXGEN MIS TIBIA PLATE PR 595004701 NEXGEN MIS TIBIA PLATE PR 595004702 NEXGEN MIS TIBIA PLATE PR 595005701 NEXGEN MIS TIBIA PLATE PR 595005702 NEXGEN MIS TIBIA PLATE PR for use in total knee arthroplasty

Quantity: 5567

Why Was This Recalled?

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zimmer Manufacturing B.V.

Zimmer Manufacturing B.V. has 91 total recalls tracked by RecallDetector.

Related Recalls

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