Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Reported: October 9, 2024 Initiated: August 29, 2024 #Z-3309-2024
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.
Details
- Recalling Firm
- Tornier, Inc
- Units Affected
- 38 units
- Distribution
- US Nationwide distribution.
- Location
- Bloomington, MN
Frequently Asked Questions
What product was recalled? ▼
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty. Recalled by Tornier, Inc. Units affected: 38 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2024. Severity: Moderate. Recall number: Z-3309-2024.
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