Z-0131-2016Class II

AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless...

Name: Z-0131-2016 AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless...
Creator: Encore Medical, Lp
Published: 2015-09-15
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2015-09-15 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation... on 2015-09-15. FDA classified it as Class II and gives the reason as "Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0131-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-15
Posted: 2015-10-16
Terminated: 2017-01-10
Recalling firm: Encore Medical, LP
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.
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, DJO Global, sent an "URGENT FIELD SAFETY NOTICE" letter dated 9/16/15 to affected consignees/customers. The letter described the product, problem, and actions to be taken. The consignees/customers were instructed quarantine the device, pass the notice on to all who need to be aware within your organization, contact customer service to place a replacement order and receive an RMA number; and to complete a response form and return the recalled device for a replacement. If you have any questions, please call (512) 834-6302 or by email at [email protected].
Quantity in commerce: 20 units
Distribution: US Distribution to states of: PA, FL, ID, and CA.
Product codes and lots: Lot: 180052L01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0131-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0131-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-16

Product code PHX

K141990Class IIEncore Humeral Shoulder StemEncore Medical L.P. / cleared 2014-11-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)