Z-1241-2018Class II

AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore...

Name: Z-1241-2018 AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore...
Creator: Encore Medical, Lp
Published: 2018-01-30
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2018-01-30 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product... on 2018-01-30. FDA classified it as Class II and gives the reason as "Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial". 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-1241-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-30
Posted: 2018-03-05
Terminated: 2023-05-30
Recalling firm: Encore Medical, LP
Product: AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
Root cause tag: design
FDA root cause: Device Design
Action: The firm disseminated their field safety notices on 01/30/2018 by email. The letter identified the affected product, problem and actions to be taken. The notices requested the trails be returned for replacement.
Quantity in commerce: 387 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot Codes: 183312L03, 200006L01, 224643L01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1241-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1241-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28

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)