Device product

DeRoyal TLIF PACK, REF 89-8780.04

Z-0626-2023

November 03, 2022

Class II

Product summary

Firm: DeRoyal Industries Inc
Event: Event 91134
Status: Ongoing
Classification: Class II
Quantity: 64 kits
Official record key: device-enforcement:Z-0626-2023

Official wording

Reason: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information: Lot Numbers: Lot 56020431 exp 9/1/2023; Lot 56390757 exp 1/1/2024

Distribution pattern: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.