LITe DECOMPRESSION recallZ-0610-2024 · Stryker Spine · initiated Nov 1, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Spine or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Stryker issued Urgent Medical Device Correction on 11/20/2023 notifying customers of removal of lot 227764 of the LITe Decompression Tube Snake Arm, catalog number 48080230. A portion of one lot of the LITe Decompression Tube Snake Arm was manufactured with the incorrect clamp component. As a result, the affected Snake Arms cannot attach to the arm post shaft. Customers are to review inventory and remove units from points of use for return to Stryker, share this information with appropriate personnel and return the Business Reply form to [email protected]. If you have any questions or concerns, please contact Regulatory Compliance at (201) 749-8090.
Recall details
- Recall number
- Z-0610-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 1, 2023
- Posted by the FDA
- Dec 21, 2023
- Recalling firm
- Stryker Spine
- Quantity
- 9
- Product code
- LXH
- Distribution
- US: MD, MI, NM, TX & OUS: Canada & France.
Product description
LITe Decompression Snake Arm, REF 48080230
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 07613327263909, lot # 227764.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LITe DECOMPRESSION 48080230Stryker Corporation · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall23 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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