LITe Decompression Snake Arm, REF 48080230

FDA device recall Z-0610-2024 · posted 2023-12-21 · Open, Classified

Recall details

Recalling firm

Stryker Spine

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

LXH

Quantity affected

9

Distribution

US: MD, MI, NM, TX & OUS: Canada & France.

Date initiated

2023-11-01

Date posted

2023-12-21

Location

Allendale, NJ