FDA recall Z-0282-2024

Encore Medical, LP · Class II · device

Product

RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.

Reason for recall

Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.

Distribution

US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA

Key facts

Status
Ongoing
Initiation date
2023-09-25
Report date
2023-11-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0282-2024