FDA recall Z-3155-2024

Tornier, Inc · Class II · device

Product

stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder

Reason for recall

One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).

Distribution

US Nationwide distribution in the states of IL, WI, AZ, NV, SD.

Key facts

Status
Ongoing
Initiation date
2024-08-29
Report date
2024-09-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3155-2024