FDA Medical Device Recalls (openFDA)
Stryker Spine: LITe Decompression Snake Arm, REF 48080230
- Recall number
- Z-0610-2024
- Recalling firm
- Stryker Spine
- Product
- LITe Decompression Snake Arm, REF 48080230
- Status
- Open, Classified
- Initiated
- 2023-11-01
- Posted
- 2023-12-21
- Terminated
- not on file
- Reason
- Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
- Root cause
- Nonconforming Material/Component
- Action
- 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 Spine-RegulatoryActions@Stryker.com. If you have any questions or concerns, please contact Regulatory Compliance at (201) 749-8090.
- Quantity
- 9
- Distribution
- US: MD, MI, NM, TX & OUS: Canada & France.
- Lot, serial or model codes
- UDI-DI (GTIN): 07613327263909, lot # 227764.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3004024955
- Firm city
- Allendale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28