Comprehensive® Reverse Shoulder 115340

• FDA 510(k) K193373 decided 15 Apr 2020 Active· +1 more in the status table
• FDA GUDID UDI-DI 00880304475335 listed 24 Oct 2015 Listed

• • Terminated Z-0619-2021 FDA Class II ·initiated 25 Nov 2020

  Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

• • Terminated Z-0093-2021 FDA Class II ·initiated 2 Sep 2020

  Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters

• • 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

  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

  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-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-2541-2011 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.

1. 22 Apr 2011 Recall initiated FDA recalls Z-2543-2011
2. 15 May 2013 Recall initiated FDA recalls Z-1548-2013
3. 24 Oct 2015 Listed FDA GUDID 00880304475335
4. 20 Dec 2016 Recall initiated FDA recalls Z-1103-2017
5. 17 Feb 2017 Recall initiated FDA recalls Z-1859-2017
6. 13 Mar 2020 Recall initiated FDA recalls Z-1750-2020
7. 15 Apr 2020 Cleared FDA 510(k) K193373
8. 17 Apr 2020 Recall initiated FDA recalls Z-2144-2020
9. 2 Sep 2020 Recall initiated FDA recalls Z-0093-2021
10. 25 Nov 2020 Recall initiated FDA recalls Z-0619-2021

12 earlier events are in the sections above.

Trade name

Comprehensive® Reverse Shoulder

Generic name

Reverse shoulder prosthesis body

Model / Ref / Catalog

115340

Primary DI / UDI-DI

00880304475335

510(k) Number

K080642 ↗

K193373 ↗

FDA product code

PAO, KWS, PHX

GMDN term

Reverse shoulder prosthesis body

Device class

Class II

Regulation number

888.3660

GUDID distribution status

In Commercial Distribution

Category: Reverse shoulder prosthesis body

Other devices filed under Reverse shoulder prosthesis body.

• LINK Embrace Shoulder System 643-010/00 by WALDEMAR LINK GmbH & Co. KG
• SMR Shoulder 1352.15.015 by Limacorporate
• GLOBAL UNITE 1407-20-101 140720101 by DEPUY (IRELAND)
• GLOBAL UNITE 1407-20-103 140720103 by DEPUY (IRELAND)
• SMR Shoulder 1352.15.051 by Limacorporate
• LINK Embrace Shoulder System 643-020/10 by WALDEMAR LINK GmbH & Co. KG

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