LITe Decompression Snake Arm cannot attach due to incorrect clamp component
Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm due to an incorrect clamp component that prevents proper attachment to the arm post shaft. Affected units were distributed in the US and internationally.
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 surgical device with a manufacturing defect preventing proper attachment, creating potential risk of device malfunction. No injuries or illnesses have been reported.
Plain-English summary
Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm (REF 48080230, lot 227764). The product arm was manufactured with an incorrect clamp component, which prevents proper attachment to the arm post shaft.
The affected units were distributed in the United States (Maryland, Michigan, New Mexico, and Texas) and internationally (Canada and France). Users should discontinue use of affected units and contact Stryker Spine for instructions.
Patients and healthcare providers who have received or used an affected LITe Decompression Snake Arm should verify the unit's lot number against the recall notice and follow manufacturer instructions for appropriate action.
The recalled product
- Product
- LITe Decompression Snake Arm, REF 48080230
- Manufacturer
- Stryker Spine
- Hazard
- component-defect
- assembly-defect
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 (2)
- UDI-DI (GTIN): 07613327263909
- lot # 227764.
Distribution
Distributed in 4 states:
- MD
- MI
- NM
- TX
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