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Recall Observatory FDA recall evidence

Device product

LITe Decompression Snake Arm, REF 48080230

Z-0610-2024

November 01, 2023

Class II

Product summary

Firm
Stryker Spine
Event
Event 93573
Status
Ongoing
Classification
Class II
Quantity
9
Official record key
device-enforcement:Z-0610-2024

Official wording

Reason: Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.

Code information: UDI-DI (GTIN): 07613327263909, lot # 227764.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.