Comprehensive® Shoulder System 118001

• • Ongoing Z-1403-2025 FDA Class II ·initiated 3 Mar 2025

  Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.

• • Terminated Z-2144-2020 FDA Class II ·initiated 17 Apr 2020

  Potential presence of elevated endotoxin levels that exceed the specification limit

• • Terminated Z-1750-2020 FDA Class II ·initiated 13 Mar 2020

  There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.

• • Terminated Z-1859-2017 FDA Class II ·initiated 17 Feb 2017

  Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

• • Terminated Z-1103-2017 FDA Class I ·initiated 20 Dec 2016 ·on shared 510(k) K080642

  Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.

• • Terminated Z-1548-2013 FDA Class II ·initiated 15 May 2013 ·on shared 510(k) K080642

  Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.

• 10 recalls, same reason

  • Terminated Z-2541-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2011
  • Terminated Z-2549-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2011
  • Terminated Z-2548-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2011
  • Terminated Z-2547-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2011
  • Terminated Z-2550-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2011
  • Terminated Z-2546-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2011
  • Terminated Z-2542-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2011
  • Terminated Z-2545-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2011
  • Terminated Z-2544-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2011
  • Terminated Z-2543-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2011

  The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.

• 2 recalls, same reason

  • Terminated Z-0712-2011 FDA Unclassified (pre-2012) ·initiated 13 Sep 2010
  • Terminated Z-0713-2011 FDA Unclassified (pre-2012) ·initiated 13 Sep 2010

  The firm received complaints regarding fracturing of the device.

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

Trade Name

Comprehensive® Shoulder System

Generic Name

Stem-fixed metallic humeral head prosthesis

Model / Ref / Catalog

118001

Primary DI / UDI-DI

00880304217249

510(k) Number

K060716 ↗

K080642 ↗

K193038 ↗

FDA Product Code

MBF, KWS, KWT, HSD, PHX

GMDN Term

Stem-fixed metallic humeral head prosthesis

Device Class

Class II

Regulation Number

888.3670, 888.3660, 888.3650, 888.3690

GUDID distribution status

In Commercial Distribution

Category: Stem-fixed metallic humeral head prosthesis

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