Tornier, Inc: Device Recall

Recall #Z-3155-2024 · 08/29/2024

Class II: Risk

Recall Details

Recall Number: Z-3155-2024
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: 5 units

Reason for Recall

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

Product Description

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

Distribution Pattern

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

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

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.

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.