—#118271

Product

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

FDA product code: PAO — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K080642
Affected lot / code info: Catalog number: 010001814 and lot numbers: 318520 and 644720.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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.

Timeline

Recall initiated: 2013-05-15
Posted by FDA: 2013-06-17
Terminated: 2014-06-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118271. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.