Z-0117-2021 Class II Terminated
FDA device recall Z-0117-2021 was initiated by Encore Medical, LP on Aug 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 Apr 19, 2024). Affected quantity: 15.
Recall details
- Product Type
- Devices
- Report Date
- Oct 28, 2020
- Initiation Date
- Aug 31, 2020
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0117-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026