Class II — Potential Health Hazard

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

ACL DISPOSABLE PACK BONE-TENDON-BONE Recalled by Stryker Corporation Due to Routine bioburden testing of certain lots were found...

Date: November 17, 2017
Company: Stryker Corporation
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 Stryker Corporation directly.

Affected Products

ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.

Quantity: 60,753 units total

Why Was This Recalled?

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.

Where Was This Sold?

Distributed domestically to . Distributed internationally to Australia and Mexico.

About Stryker Corporation

Stryker Corporation has 108 total recalls tracked by RecallDetector.

Related Recalls

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