Class II — Potential Health Hazard

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

PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Recalled by Zimmer, Inc. Due to Foreign Object Contamination

Date: April 30, 2015
Company: Zimmer, 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, Inc. directly.

Affected Products

PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument

Quantity: 1,689

Why Was This Recalled?

Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zimmer, Inc.

Zimmer, Inc. has 437 total recalls tracked by RecallDetector.

Related Recalls

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