Recall Z-1548-2013 ยท PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Biomet, Inc.
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
| Date | Jun 17, 2013 (initiated May 15, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080642 | COMPREHENSIVE REVERSE SHOULDER Biomet, Inc., Jul 9, 2008 |