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Encore Medical, LP recalls AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU,
Recalled October 28, 2020 · FDA recall Z-0117-2021 · Encore Medical
Hazard
Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery. · FDA Class II
Units
15
Sold at
US Nationwide distribution.
Description
Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
Product
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.
Manufacturer(s)
Encore Medical, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →