Maestro Total Wrist 180353

• • 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-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-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-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-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

Maestro Total Wrist

Generic Name

Orthopaedic bone pin, non-bioabsorbable

Model / Ref / Catalog

180353

Primary DI / UDI-DI

00880304479579

510(k) Number

K080426 ↗

K080642 ↗

FDA Product Code

KWS, JWJ, PAO

GMDN Term

Orthopaedic bone pin, non-bioabsorbable

Device Class

Class II

Regulation Number

888.3660, 888.3800

GUDID distribution status

In Commercial Distribution

Category: Orthopaedic bone pin, non-bioabsorbable

• Taperloc® Complete

  Class IIa

  CE/MDR

• Long Post Connection

  Class IIa

  CE/MDR

• Taperloc® Complete

  Class IIa

  CE/MDR

• Taperloc® Complete

  Class IIa

  CE/MDR

• Taperloc® Complete

  Class I

  CE/MDR

• Taperloc® Complete

  Class IIa

  CE/MDR

See all devices from Biomet Orthopedics, Inc. →