FDA recall Z-0610-2024

Product

LITe Decompression Snake Arm, REF 48080230

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2023-11-01

Report date

2023-12-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allendale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0610-2024