Stryker Hoffmann II Connecting Rod Micro Recalled Due to Potential Cracking
Stryker is recalling Hoffmann II Connecting Rod Micro 3 x 30mm (catalog 50796030) because the rods may crack after cleaning and sterilization. FDA has classified this as Class II.
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 of a medical device with potential cracking after cleaning and sterilization. No hospitalization reports are mentioned in the source, so this falls under the rubric's High category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker GmbH is recalling the Hoffmann II Connecting Rod Micro 3 x 30mm, catalog number 50796030 (GTIN 04546540389893). The recall covers all lot numbers of this catalog number, totaling 4,505 units distributed worldwide, including nationwide distribution in the US and in numerous other countries. The FDA recall number is Z-2827-2026.
The recall was initiated because the connecting rods may crack following cleaning and sterilization. Potential cracking could affect the device's performance. The FDA has classified this recall as Class II.
Healthcare providers and distributors should check their inventory for the affected catalog number and lot numbers and follow the recalling firm's instructions for return or replacement. Anyone with questions should contact Stryker GmbH or refer to the FDA recall notice.
The recalled product
- Product
- Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
- Manufacturer
- Stryker GmbH
- Affected units
- 4,505
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: 50796030. GTIN: 04546540389893. 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 After Sterilization
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- HighStryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking
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Same hazard · device cracking
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