FDA recall Z-0349-2025

Product

CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A

Reason for recall

Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.

Distribution

US Nationwide distribution in the state of TN.

Key facts

Status

Ongoing

Initiation date

2024-10-04

Report date

2024-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0349-2025