Use caution Medical device recall · FDA · Published February 10, 2021

Howmedica knee prosthesis recall: Oversized baseplate may prevent lock

Howmed: Howmedica recalls knee prostheses with Lot CTD44301 due to oversized baseplate that may prevent insert from locking. Affected units have specific model and lot number.

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

🇺🇸 FDA recall #Z-1186-2021Medical device Howmedica ›

Use caution until it’s fixed

Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.

Take action

Contact the company

Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006

✎ GovInfoNow plain-language explainer

Howmedica is recalling knee prostheses with Lot Number CTD443: the baseplate may be oversized, preventing the insert from locking securely. This could lead to instability or dislocation of the joint. Read more at govinfonow.com/recall/63283-howmedica-knee-prosthesis-recall-oversized-baseplate-may-prevent-lock.

Source Summary by GovInfoNow · govinfonow.com/recall/63283-howmedica-knee-prosthesis-recall-oversized-baseplate-may-prevent-lock · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1186-2021

Cite this page

“Howmedica knee prosthesis recall: Oversized baseplate may prevent lock.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63283-howmedica-knee-prosthesis-recall-oversized-baseplate-may-prevent-lock. Based on FDA recall #Z-1186-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1186-2021%22&limit=1).

The FDA announced on Feb. 10, 2021, that Howmedica Osteonics Corp. recalled a knee prosthesis due to a manufacturing issue that may prevent the insert from locking onto the baseplate. The agency classified the recall as Class II.

How to tell if you have it

Brand: Howmedica
Product: Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Catalogue #: 5536-B-400
Lot Number: CTD44301
Size: 4 (Triathlon Tritanium Tibial Component Baseplate)
Quantity: 11 devices

The hazard

Stryker discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized due to a manufacturing issue in Lot Number CTD44301. A witness mark (taper) at the bottom of the internal profile may prevent the insert from locking on the baseplate.

Context

GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Other recent recalls include the Howmedica DURACON XL Angled Tibial Implants Recall (July 30, 2026), the Howmedica Triathlon Baseplate Size 3 Recall (May 19, 2026), and the Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (Feb. 2, 2026). Other recent recalls of similar products include the U2 Total Knee System PSA Box Trial (May 20, 2026), the Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall (Jan. 5, 2026), and the U2 Total Knee System Femoral Valgus Adaptor Recall (May 20, 2026).

How to tell if you have this one

Check for Catalogue # 5536-B-400 and Lot Number CTD44301 on the prosthesis packaging or label. The recall applies to knee prostheses sold with this specific lot number.

Brand
Howmedica
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Prosthesis Details
Look for Catalogue # 5536-B-400 and Lot Number CTD44301 on the prosthesis packaging or label.

Where it went and when

Where it was distributed

Distributed in 13 states.

FDA distribution: “Domestic: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Georgia, Massachusetts, Michigan, Minnesota, New Hampshire, New Jersey, Oregon, Pennsylvania, South Carolina, Utah, Washington, West Virginia.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

Feb 10, 2021Firm started the recall
Mar 8, 2021FDA classified it Class II
Mar 17, 2021Published in FDA’s Enforcement Report
May 30, 2023FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/63283-howmedica-knee-prosthesis-recall-oversized-baseplate-may-prevent-lock">Howmedica knee prosthesis recall: Oversized baseplate may prevent lock (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-1186-2021 (February 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1186-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.