Recall Z-0716-2014 ยท HRS Plate, Fixation, Bone
Biomet, Inc.
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
| Date | Jan 10, 2014 (initiated Dec 19, 2013) |
| Status | Terminated |
| Reason | 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw. |
| Root cause | Labeling mix-ups |
| Action | URGENT MEDICAL DEVICE RECALL notices were sent to all consignees on December 19, 2013. Distributors who have affected hospitals in their regions were notified and provided with a copy of the notice that went to each hospital. Consignees are being contacted on an individual basis in an attempt to reconcile the product 100%. Fax back forms were provided to all consignees in order for Biomet to track returns. Non-responders will be contacted on an individual basis. |
| Quantity | 52 |
| Distribution | US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA. |
| FDA record | Open on fda.gov |