Biomet, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1548-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.

Product Classification:

Class II

Date Initiated: May 15, 2013

Date Posted: June 26, 2013

Recall Number: Z-1548-2013

Event ID: 65212

Reason for Recall:

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.

Status: Terminated

Product Quantity: 17

Code Information:

Catalog number: 010001814 and lot numbers: 318520 and 644720.

Distribution Pattern:

Worldwide Distribution-USA (nationwide) including the states of UT, TX, AL, KY, and WI, and the countries of Australia, The Netherlands, Korea, and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated