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.
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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