Lower risk Medical device recall · FDA · Published January 25, 2018

Stryker CMI Meniscus Implant: Risk of Temperature Damage During Shipping

Stryker recalls collagen-based meniscus implants that may have been exposed to high temperatures during shipping, potentially affecting safety. Learn which models are affected and what to do.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0974-2018Medical device Stryker ›

Lower-risk recall

The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.

Take action

Contact the company

Recalling firmStryker Corporation5900 Optical Ct · San Jose, CA 95138-1400

✎ GovInfoNow plain-language explainer

Stryker is recalling collagen-based meniscus implants that could have been damaged by high temperatures during shipping. This might affect the implant's safety and effectiveness if used. Read more at govinfonow.com/recall/72099-stryker-cmi-meniscus-implant-risk-of-temperature-damage-during-shipping.

Source Summary by GovInfoNow · govinfonow.com/recall/72099-stryker-cmi-meniscus-implant-risk-of-temperature-damage-during-shipping · Updated August 28, 2026 · FDA enforcement record: FDA #Z-0974-2018

Cite this page

“Stryker CMI Meniscus Implant: Risk of Temperature Damage During Shipping.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/72099-stryker-cmi-meniscus-implant-risk-of-temperature-damage-during-shipping. Based on FDA recall #Z-0974-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0974-2018%22&limit=1).

The FDA announced on Jan. 25, 2018, that Stryker Corporation voluntarily recalled CMI collagen-based meniscus implants because they were shipped without required temperature control packaging. The agency stated the devices could have been exposed to elevated temperatures during transit.

How to tell if you have it

Brand: Stryker
Product: CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant
Affected Lot Codes: 4600: 15J456; 4601: 16A463, 16G470, 17F510; 4607: 16A461, 16D465, 16E467, 16F468, 17E506, 17E507; 4612: 16A458, 16A459, 17D489, 17E503, 17E504
Quantity: 155 devices
Distribution: Netherlands

The hazard

According to the FDA, the recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.

Context

GovInfoNow's records show Stryker Corporation has 34 other recalls on record since Nov. 17, 2017. Other recent recalls include the Stryker Single Spike Tube Set (June 8, 2026), the Stryker Neptune Smart Docking Station (May 6, 2026), and the Stryker FluidSmart Urology Tube Set (April 9, 2026). Other recent recalls of similar products include the I.T.S. GmbH FR.O.H. Calcaneus Repair System (Jan. 23, 2026), the I.T.S. GmbH Pelvic Reconstruction System (Jan. 23, 2026), and the I.T.S. Foot Locking Plates System (Jan. 23, 2026).

How to tell if you have this one

Check the serial numbers listed: 4600 (15J456), 4601 (16A463, 16G470, 17F510), 4607 (16A461, 16D465, 16E467, 16F468, 17E506, 17E507), and 4612 (16A458, 16A459, 17D489, 17E503, 17E504).

Brand
Stryker
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Look for the specific serial numbers listed in the recall notice: 4600 (15J456), 4601 (16A463, 16G470, 17F510), 4607 (16A461, 16D465, 16E467, 16F468, 17E506, 17E507), and 4612 (16A458, 16A459, 17D489, 17E503, 17E504).

How this recall unfolded

Recall timeline

FDA published this recall 55 days after the firm started it.

Jan 25, 2018Firm started the recall
Mar 12, 2018FDA classified it Class II
Mar 21, 2018Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What is the CMI meniscus implant used for?

The CMI device is a collagen-based implant designed to help repair knee tissue in patients with irreparable meniscus tears or loss of meniscus tissue.

Similar recalls

Latest medical device recalls

Keep exploring

More Stryker recalls

Link to this recall

<a href="https://govinfonow.com/recall/72099-stryker-cmi-meniscus-implant-risk-of-temperature-damage-during-shipping">Stryker CMI Meniscus Implant: Risk of Temperature Damage During Shipping (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0974-2018 (January 25, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0974-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.