FDA Medical Device Recalls (openFDA)
Stryker GmbH: Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
- Recall number
- Z-2829-2026
- Recalling firm
- Stryker GmbH
- Product
- Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
- Status
- Open, Classified
- Initiated
- 2026-07-01
- Posted
- 2026-07-29
- Terminated
- not on file
- Reason
- Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 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
- 7,571 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.
- Lot, serial or model codes
- Catalog Number: 50796050. GTIN: 04546540389916. All lot numbers.
- 510(k) numbers
- ["K033476"]
- PMA numbers
- not on file
- Product code
- KTT
- Firm FEI
- 3002807830
- Firm city
- Selzach
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28