Z-0610-2024Class II

LITe Decompression Snake Arm, REF 48080230

Name: Z-0610-2024 LITe Decompression Snake Arm, REF 48080230
Creator: Stryker Spine
Published: 2023-11-01
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2023-11-01 / Open, Classified / root cause: manufacturing process

FDA source

Stryker Spine began a recall of LITe Decompression Snake Arm, REF 48080230 on 2023-11-01. FDA classified it as Class II and gives the reason as "Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0610-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-01
Posted: 2023-12-21
Recalling firm: Howmedica Osteonics Corp
Product: LITe Decompression Snake Arm, REF 48080230
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected]. If you have any questions or concerns, please contact Regulatory Compliance at (201) 749-8090.
Quantity in commerce: 9
Distribution: US: MD, MI, NM, TX & OUS: Canada & France.
Product codes and lots: UDI-DI (GTIN): 07613327263909, lot # 227764.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0610-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0610-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-21

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)