FDA Medical devices recall ·
Stryker Tornier Perform Humeral System, Reversed Insert, 45% recall
- Recall number
- Z-3309-2024
- Date
- (initiated August 29, 2024)
- Company / brand
- Tornier, Inc
10801 Nesbitt Ave S, Bloomington, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 38 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN 00846832084494, Batch Lot # 1495AY
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3309-2024. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.