FDA recall Z-0117-2021

Encore Medical, LP · Class II · device

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.

Reason for recall

Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2020-08-31
Report date
2020-10-28
Termination date
2024-04-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0117-2021