Comprehensive Primary Shoulder Stems

• • Terminated Z-1543-2020 FDA Class II ·initiated 17 Feb 2020

  A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.

• • Terminated Z-0591-2019 FDA Class II ·initiated 10 Oct 2018

  Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.

• 2 recalls, same reason

  • Terminated Z-0979-2018 FDA Class II ·initiated 8 Dec 2017 ·on shared 510(k) K060692
  • Terminated Z-0980-2018 FDA Class II ·initiated 8 Dec 2017 ·on shared 510(k) K060692

  Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.

• • Terminated Z-0299-2018 FDA Class II ·initiated 5 Jun 2017

  Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

• • Terminated Z-1755-2015 FDA Class III ·initiated 16 Apr 2015

  Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K060692 ↗

FDA Product Code

MBF

Device Class

Class II

Regulation

21 CFR Part 888.3670

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Comprehensive® Convertible Glenoid - Vivacit-E Liner

  Class II

  FDA 510(k) K211729 Active Cleared 4 Nov 2021

• Modular Hybrid Glenoid

  Class II

  FDA 510(k) K060694 Active Cleared 11 Dec 2006

• Altra Press-Fit Hip System

  Class III

  FDA 510(k) K063002 Active Cleared 31 Oct 2006

• Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits

  Class II

  FDA 510(k) K141219 Active Cleared 18 Jul 2014

• Biomet Headless Compression and Twist-off Screws

  Class II

  FDA 510(k) K142658 Active Cleared 13 Nov 2014

• ExpressBraid Graft Manipulation

  Class II

  FDA 510(k) K152868 Active Cleared 8 Feb 2016

See all devices from Biomet Manufacturing Corp →

• What are the Comprehensive Primary Shoulder Stems used for?

  These stems are titanium alloy humeral implants designed for use in either hemi or total shoulder arthroplasty procedures. They function as semi-constrained shoulder prostheses to support joint reconstruction.

• How are these shoulder stems fixed in the bone?

  The stems are designed to support both cemented and uncemented fixation. For uncemented applications, the device features a plasma-spray titanium porous coating to facilitate biological fixation.

• Are these stems compatible with other shoulder components?

  These stems are intended for use exclusively with specific Biomet humeral heads and glenoid components. Clinicians must ensure they are using the compatible Biomet components as specified by the manufacturer for the system to function as intended.