Z-0117-2021 Class II Terminated
FDA device recall Z-0117-2021 was initiated by Encore Medical, LP on August 31, 2020 and is designated Class II. Reason for recall: Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery. The recall status is terminated (terminated April 19, 2024). Affected quantity: 15.
Recall Details
- Product Type
- Devices
- Report Date
- October 28, 2020
- Initiation Date
- August 31, 2020
- Termination Date
- April 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15
Product Description
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 Pattern
US Nationwide distribution.
Code Information
Lot Number: 964W1000