Tornier, Inc: Device Recall

Recall #Z-3309-2024 · 08/29/2024

Class II: Risk

Recall Details

Recall Number: Z-3309-2024
Classification: Class II
Product Type: Device
Recalling Firm: Tornier, Inc
Status: Ongoing
Date Initiated: 08/29/2024
Location: Bloomington, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 38 units

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.

Product Description

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

Distribution Pattern

US Nationwide distribution.

Other Recalls by Tornier, Inc

Class II: Risk 12/19/2025

A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
Class II: Risk 03/03/2025

A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)
Class II: Risk 08/29/2024

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

View all recalls by Tornier, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.