Recall Z-3309-2024— Tornier, Inc
Class II · Ongoing
Class II FDA medical device recall by Tornier, Inc, initiated 2024-08-29. It names one FDA 510(k) clearance: K201315. Product: Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty. Reason: 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..
- Recalling firm
- Tornier, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-29
- Firm location
- Bloomington, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.