FDA recall Z-2415-2023

Product

Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device

Reason for recall

Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.

Distribution

US and Canada

Key facts

Status

Ongoing

Initiation date

2023-07-13

Report date

2023-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Vernon Hills, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2415-2023