Z-3309-2024 Class II Ongoing

Recalled by Tornier, Inc — Bloomington, MN

Recall Details

Product Type
Devices
Report Date
October 9, 2024
Initiation Date
August 29, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
38 units

Product Description

Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

Reason for Recall

Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.

Distribution Pattern

US Nationwide distribution.

Code Information

GTIN 00846832084494, Batch Lot # 1495AY