Comprehensive Shoulder System 405315

• FDA 510(k) K193038 decided 28 Oct 2020 Active· +2 more in the status table
• FDA GUDID UDI-DI 00880304560949 listed 27 Oct 2016 Listed

• • 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 ·on shared 510(k) K080642

  Potential presence of elevated endotoxin levels that exceed the specification limit

• • Terminated Z-1750-2020 FDA Class II ·initiated 13 Mar 2020 ·on shared 510(k) K080642

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

• • 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-0980-2018 FDA Class II ·initiated 8 Dec 2017
  • Terminated Z-0979-2018 FDA Class II ·initiated 8 Dec 2017

  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-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

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

• • 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.

• • Terminated Z-1548-2013 FDA Class II ·initiated 15 May 2013

  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-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-2541-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2011
  • Terminated Z-2549-2011 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.

1. 17 Feb 2017 Recall initiated FDA recalls Z-1859-2017
2. 5 Jun 2017 Recall initiated FDA recalls Z-0299-2018
3. 8 Dec 2017 Recall initiated FDA recalls Z-0980-2018
4. 8 Dec 2017 Recall initiated FDA recalls Z-0979-2018
5. 10 Oct 2018 Recall initiated FDA recalls Z-0591-2019
6. 17 Feb 2020 Recall initiated FDA recalls Z-1543-2020
7. 13 Mar 2020 Recall initiated FDA recalls Z-1750-2020
8. 17 Apr 2020 Recall initiated FDA recalls Z-2144-2020
9. 28 Oct 2020 Cleared FDA 510(k) K193038
10. 3 Mar 2025 Recall initiated FDA recalls Z-1403-2025

18 earlier events are in the sections above.

Trade name

Comprehensive Shoulder System

Generic name

Humeral stem prosthesis trial, reusable

Model / Ref / Catalog

405315

Primary DI / UDI-DI

00880304560949

510(k) Number

K060692 ↗

K080642 ↗

K193038 ↗

FDA product code

KWS, PAO, HSD, KWT, MBF

GMDN term

Humeral stem prosthesis trial, reusable

Device class

Class II

Regulation number

888.3660, 888.3690, 888.3650, 888.3670

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Humeral stem prosthesis trial, reusable

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