FDA-Device2020-10-28Class II
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.
Encore Medical, LP
Hazard
Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
Sold states
US Nationwide distribution.
Affected count
15
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0117-2021Don't want to check this manually?
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