Recall Z-0131-2016— Encore Medical, Lp

Name: FDA recall Z-0131-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-15

Class II · Terminated

Class II FDA medical device recall by Encore Medical, Lp, initiated 2015-09-15, terminated 2017-01-10. It names one FDA 510(k) clearance: K141990. Product: 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: Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw..

Recalling firm: Encore Medical, Lp
Classification: Class II
Status: Terminated
Initiated: 2015-09-15
Terminated: 2017-01-10
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K141990 — ENCORE HUMERAL SHOULDER STEMEncore Medical L.P.·cleared 2014-11-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.