Stryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking
Stryker GmbH is recalling Hoffmann II Carbon Connecting Rods (catalog 50796060) because they may crack after cleaning and sterilization. The recall covers all lots and about 9,658 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: FDA Class II recall involving potential cracking of a medical device; no injury is reported in the source, so this fits the 'risk-of-harm products where injury has not yet been reported' High criterion.
Plain-English summary
Stryker GmbH is recalling the Stryker Hoffmann II Connecting Rod Micro 3 x 60mm, catalog number 50796060. The recall includes all lot numbers and approximately 9,658 units. The recalled product is a carbon connecting rod.
The recall was initiated because the carbon connecting rods may crack following cleaning and sterilization. The U.S. Food and Drug Administration has classified this action as Class II.
The recall affects distribution in the United States and worldwide. Anyone with catalog number 50796060 should check whether their units are included and follow the recalling firm's instructions.
The recalled product
- Product
- Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.
- Manufacturer
- Stryker GmbH
- Category
- Medical Device — Connecting Rod
- Hazard
- device-cracking
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: 50796060. GTIN: 04546540389923. All lot numbers.
Distribution
Distributed nationwide across the United States.
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