Recall Z-0626-2016— Encore Medical, Lp

Name: FDA recall Z-0626-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-08

Class II · Terminated

Class II FDA medical device recall by Encore Medical, Lp, initiated 2015-12-08, terminated 2016-03-01. It names one FDA 510(k) clearance: K141990. 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.. Reason: The trial shell mating feature on the broach is undersized..

Recalling firm: Encore Medical, Lp
Classification: Class II
Status: Terminated
Initiated: 2015-12-08
Terminated: 2016-03-01
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 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.

Reason for recall

The trial shell mating feature on the broach is undersized.

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