Comprehensive® SRS Instrument 405202

• FDA 510(k) K111746 decided 15 Dec 2011 Active· +1 more in the status table
• FDA GUDID UDI-DI 00887868504075 listed 23 Apr 2022 Listed

• • 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-1173-2018 FDA Class II ·initiated 28 Feb 2018

  During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.

• • 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-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.

1. 22 Apr 2011 Recall initiated FDA recalls Z-2544-2011
2. 22 Apr 2011 Recall initiated FDA recalls Z-2543-2011
3. 15 Dec 2011 Cleared FDA 510(k) K111746
4. 15 May 2013 Recall initiated FDA recalls Z-1548-2013
5. 20 Dec 2016 Recall initiated FDA recalls Z-1103-2017
6. 17 Feb 2017 Recall initiated FDA recalls Z-1859-2017
7. 28 Feb 2018 Recall initiated FDA recalls Z-1173-2018
8. 13 Mar 2020 Recall initiated FDA recalls Z-1750-2020
9. 17 Apr 2020 Recall initiated FDA recalls Z-2144-2020
10. 23 Apr 2022 Listed FDA GUDID 00887868504075

11 earlier events are in the sections above.

Trade name

Comprehensive® SRS Instrument

Generic name

Humeral stem prosthesis trial, reusable

Model / Ref / Catalog

405202

Primary DI / UDI-DI

00887868504075

510(k) Number

K080642 ↗

K111746 ↗

FDA product code

JDC, KWT, KWS, MBF, PAO

GMDN term

Humeral stem prosthesis trial, reusable

Device class

Class II

Regulation number

888.3150, 888.3650, 888.3660, 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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