Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.
Summary
The FDA issued a Class II for Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060. by Stryker GmbH. Reason: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization..
Details
Source
Device Recall
External ID
Z-2830-2026
Action Date
2026-08-05
Status
Ongoing
Category
device
Product Description
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.
Lot/Code Info: Catalog Number: 50796060. GTIN: 04546540389923. All lot numbers.
Quantity Affected: 9,658 units
Reason for Recall
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Distribution
Worldwide - US Nationwide distribution including in the states of 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 the countries of Australia, Austria, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-01
Company
Selzach, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 136 device recalls issued in the same week, part of 341 device-related FDA actions this month.
Stryker GmbH has 36 FDA actions in our database, including 15 recalls and 21 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker GmbH have FDA actions?
Stryker GmbH has 36 FDA actions in our database, including 15 recalls and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2830-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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