Class II — Potential Health Hazard

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

Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Recalled by Zimmer Gmbh Due to Potential compromise of the inner sterile tray. If...

Date: December 17, 2014
Company: Zimmer Gmbh
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 Gmbh directly.

Affected Products

Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck lengths are available for various patient anatomies and adjustment of the tension of the ligaments and reconstruction of the center of the natural head of the femur.

Quantity: 10340

Why Was This Recalled?

Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

Where Was This Sold?

This product was distributed to 45 states: AL, AK, AZ, AR, CA, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY

Affected (45 states)Not affected

About Zimmer Gmbh

Zimmer Gmbh has 14 total recalls tracked by RecallDetector.

Related Recalls

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