Stryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
Stryker GmbH is recalling Stryker Hoffmann II Connecting Rod Micro 3 x 50mm due to a potential risk of the rods cracking after cleaning and sterilization.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The product is a medical device with a high-risk hazard (potential structural failure/cracking) where injury has not yet been reported.
Plain-English summary
Stryker GmbH is recalling Stryker Hoffmann II Connecting Rod Micro 3 x 50mm (Catalog Number: 50796050). The recall is being conducted because the rods may potentially crack following cleaning and sterilization processes.
This recall affects approximately 7,571 units distributed worldwide, including nationwide in the United States and in several other countries such as Australia, Canada, Germany, and the UK.
Users should be aware of the potential for rod cracking after sterilization procedures.
The recalled product
- Product
- Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
- Manufacturer
- Stryker GmbH
- Affected units
- 7,571
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: 50796050. GTIN: 04546540389916. All lot numbers.
Distribution
Part of a larger recall action
This product is one of 7 recalled by Stryker GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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- HighStryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking
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- Severe
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