Z-2831-2026Class II

Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090

Name: Z-2831-2026 Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090
Creator: Stryker GmbH
Published: 2026-07-01
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2026-07-01 / Open, Classified / root cause: design

FDA source

Stryker GmbH began a recall of Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090 on 2026-07-01. FDA classified it as Class II and gives the reason as "Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2831-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-01
Posted: 2026-07-29
Recalling firm: Stryker Corp.
Product: Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Root cause tag: design
FDA root cause: Device Design
Action: Firm began notifying consignees on July 1, 2026. Customers were instructed to immediately check their internal inventory to locate affected product. Customers were informed that until further notice, the subject devices are limited to single use only. Following first use, discard the devices in accordance with the facility's established procedures. Users should conduct visual inspection of product prior to each use. If cracking is found to be present, the customer should quarantine non-confirming parts and report the issue to Stryker's Trauma & Extremities division. Rods with cracks should be returned as part of the complaint process.
Quantity in commerce: 9,405 units
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.
Product codes and lots: Catalog Number: 50796090. GTIN: 04546540389930. All lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2831-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2827-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-29
Z-2828-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-29
Z-2829-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-29
Z-2830-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-29
Z-2831-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-29
Z-2832-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-29
Z-2833-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-29

Product code KTT

K033476Class IIModification to Hoffmann II Micro External Fixation SystemHowmedica Osteonics Corp. / cleared 2004-01-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)