Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
FDA device recall Z-2827-2026 · posted 2026-07-29 · Open, Classified
Recall details
- Recalling firm
- Stryker GmbH
- Reason for recall
- Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KTT
- Quantity affected
- 4,505 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 cou
- Date initiated
- 2026-07-01
- Date posted
- 2026-07-29
- Location
- Selzach, Switzerland
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM (K033476) | Howmedica Osteonics Corp. | 2004-01-20 |