Z-0626-2016Class II

AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and...

Name: Z-0626-2016 AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and...
Creator: Encore Medical, Lp
Published: 2015-12-08
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2015-12-08 / Terminated / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic... on 2015-12-08. FDA classified it as Class II and gives the reason as "The trial shell mating feature on the broach is undersized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0626-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-08
Posted: 2016-01-09
Terminated: 2016-03-01
Recalling firm: Encore Medical, LP
Product: AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: The trial shell mating feature on the broach is undersized.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm notified customers of the recall via letter on 12/8/15.
Quantity in commerce: 23 units
Distribution: Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX
Product codes and lots: 178881L05, 178881L06, 183345L03, 178881L09, 178881L10, 183345L05, 178881L11, 178881L12, 183345L06

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0626-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0626-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-09

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)