Stryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking After Sterilization
Stryker is recalling Hoffmann II Carbon Connecting Rods (catalog 50796120) because the rods may crack after cleaning and sterilization. The recall covers 5,439 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with potential cracking that could pose a risk of harm. No injuries or hospitalizations are reported in the source, so the High rubric criterion for risk-of-harm products without reported injury applies.
Plain-English summary
Stryker GmbH is recalling the Stryker Hoffmann II Connecting Rod Micro 3 x 120mm, catalog number 50796120. The recall includes all lot numbers of this catalog item, with GTIN 04546540389947.
The reason for the recall is potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. This could affect the structural integrity of the device.
The affected product was distributed in the United States and worldwide, including the states and countries listed in the recall notice. The recall covers 5,439 units.
Healthcare providers and users should check inventory for the affected catalog number and follow the recalling firm's guidance for returning or handling affected product.
The recalled product
- Product
- Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.
- Manufacturer
- Stryker GmbH
- Hazard
- device-cracking
- implant-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 50796120. GTIN: 04546540389947. All lot numbers.
Distribution
Distributed nationwide across the United States.
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