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Recall Observatory FDA recall evidence

Device product

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

Z-1548-2013

May 15, 2013

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 65212
Status
Terminated
Classification
Class II
Quantity
17
Official record key
device-enforcement:Z-1548-2013

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.