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Biomet, Inc. Recall: Superior Approach Resection Guide Assembly. Indicated for primary, fr

Biomet, Inc. Recall: Superior Approach Resection Guide Assembly. Indicated for primary, fr is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Biomet, Inc.; Product: Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the

Recalling firmBiomet, Inc.
ProductSuperior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
Reason for recallBiomet 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide Distribution-USA (nationwide) including the states of UT, TX, AL, KY, and WI, and the countries of Australia, The Netherlands, Korea, and Canada.
Recall initiated20130515
Recall numberZ-1548-2013
Categorydevice
StateIN
CountryUnited States

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