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Recall Observatory FDA recall evidence

Device product

Total Hip Kit, REF DYNJ903275S; surgical convenience kit

Z-2366-2023

July 03, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 92736
Status
Ongoing
Classification
Class II
Quantity
16 kits
Official record key
device-enforcement:Z-2366-2023

Official wording

Reason: The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.

Code information: UDI/DI: 10195327254582 (unit), 40195327254583 (case); Lot code 23CDC733

Distribution pattern: US Nationwide distribution in the state of Illinois.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.