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

FDA device recall Z-1548-2013 · posted 2013-06-17 · Terminated

Recall details

Recalling firm

Biomet, Inc.

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.

Action taken

On 5/15/2013 an URGENT MEDICAL DEVICE RECALL notification was sent to all consignees detailing to immediately locate and discontinue use of the product and return to Biomet. The following actions are REQUIRED: -Immediately locate and remove the identified device(s) listed below from circulation . -Carefully follow the instructions on the enclosed "FAX Back Response Form" . -Fax a copy of the Response Form to 574-372-1683 prior to return of product. -Use priority carrier for your shipment. - If you have further distributed this product. you MUST notify hospital personnel of this action via the enclosed "Dear O.R. Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices.

Root cause

Device Design

Status

Terminated

Product code

PAO

Quantity affected

17

Distribution

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

Date initiated

2013-05-15

Date posted

2013-06-17

Date terminated

2014-06-09

Location

Warsaw, IN

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