FDA Closes Recall Action for Stryker Hoffmann II Connecting Rods

The agency considers the recall completed for 6,244 connecting rods affected by potential cracking risks.

2 reports on this incident · first at Aug 20, 2026, 4:23 a.m. ET

By AI ReporterWritten Aug 20, 2026, 4:24 a.m. ET

The Food and Drug Administration has closed its action regarding the recall of Stryker Hoffmann II Connecting Rod Micro 3 x 40mm devices on August 5, 2026, signifying that the agency considers the recall carried out. The recall, initiated by on July 1, 2026, involved due to potential cracking of the carbon connecting rods following cleaning and sterilization. According to FDA enforcement report records for recall number , the action was classified as on August 5, 2026. is the FDA's middle classification category, applied when a product may cause temporary or medically reversible adverse health consequences, and where the probability of serious harm is remote. FDA database records show no other enforcement actions for . For anyone who still has the product, the affected devices carry Catalog Number: 50796040, GTIN: 04546540389909, and include all lot numbers. FDA enforcement report records list distribution worldwide, including nationwide in the U.S. across states including AL, AZ, CA, CO, FL, GA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA, WI, WV and countries including Australia, Austria, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and the UK. The cause has not been determined.

Earlier reports

Aug 20, 2026, 4:23 a.m. ETFirst report
FDA Report Details Class II Recall of Stryker Connecting Rods
On August 5, 2026, the Food and Drug Administration (FDA) published an enforcement report detailing an ongoing recall of medical devices manufactured by Stryker GmbH. The action was initiated on July 1, 2026, and remains open and developing.
The recall involves 6,244 units of the Stryker Hoffmann II Connecting Rod Micro 3 x 40mm, under Catalog Number 50796040, GTIN 04546540389909, and all lot numbers, designated under recall number Z-2828-2026. The FDA report attributes the action to potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Distribution was worldwide and US nationwide, including AL, AZ, CA, CO, FL, GA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA, WI, and WV, as well as Australia, Austria, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and the UK.
Class II is the FDA's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. FDA database listings document no other enforcement action for Stryker GmbH.

Was this report accurate and useful?

Sources

Revision history

Version 120 Aug 2026, 08:23current
First published.
Version 120 Aug 2026, 08:35
First published.
Version 120 Aug 2026, 08:24current
First published.

How we work

This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.

Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.

Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.

None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.