Z-0131-2016 Class II Terminated
FDA device recall Z-0131-2016 was initiated by Encore Medical, Lp on Sep 15, 2015 and is designated Class II. Reason for recall: Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw. The recall status is terminated (terminated Jan 10, 2017). Affected quantity: 20 units.
Recall details
- Product Type
- Devices
- Report Date
- Oct 28, 2015
- Initiation Date
- Sep 15, 2015
- Termination Date
- Jan 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product description
AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of previously failed surgical attempts. Shoulder reconstructive surgery should be reserved for patients who have failed non-operative treatments.
Reason for recall
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
Distribution pattern
US Distribution to states of: PA, FL, ID, and CA.
Code information
Lot: 180052L01
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0131-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026