Recall Z-1439-2012 ยท HRS Plate, Fixation, Bone
Biomet, Inc.
Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany, NJ 97054. Cortical Locking Screw for securing a Proximal Humeral Plate to the bone in the Optilock system.
| Date | Apr 19, 2012 (initiated Mar 15, 2012) |
| Status | Terminated |
| Reason | Biomet initiated this action after a complaint was received that item 36728, Non-Locking Screw 3.5mm x 28mm was in a package labeled as 37728, Locking Screw 3.5mm x 28mm. |
| Root cause | Labeling mix-ups |
| Action | A March 15 2012 Urgent Medical Device Recall Notice was sent to Distributors, Operating Room Managers, and Physicians with directions to locate and remove recalled items with instructions to provide the recall notice to any sub-accounts. The letter also identified the affected product and explained the reason for the recall. OR Managers and Physicians are to confirm recall notice receipt by calling 800-348-9500, extention 3983 or 3009 and make arrangements for product return. Distributors are to complete and FAX back the response tracking form to the attention of Angi Dickson, Biomet @ 574- |
| Quantity | 45 |
| Distribution | Worldwide Distribution -- USA, including NJ, TX, VA, MI IL, KT, & Puerto Rico, and country of the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062494 | EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM Ebi, L.P., Oct 19, 2006 |