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.
Reported: October 28, 2015 Initiated: September 15, 2015 #Z-0131-2016
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.
Details
- Recalling Firm
- Encore Medical, Lp
- Units Affected
- 20 units
- Distribution
- US Distribution to states of: PA, FL, ID, and CA.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Encore Medical, Lp. Units affected: 20 units.
Why was this product recalled? ▼
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2015. Severity: Moderate. Recall number: Z-0131-2016.
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