FDAFDA · Food and drugs·Recall number Z-0117-2021
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
Published October 28, 2020 · Recall initiated: August 31, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Encore Medical, LP
- Distributor
- US Nationwide distribution.
- Lot
- Lot Number: 964W1000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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