Recall Z-0882-2021 ยท HRS Plate, Fixation, Bone
Biomet, Inc.
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.
| Date | Jan 21, 2021 (initiated Dec 23, 2020) |
| Status | Terminated |
| Reason | The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill. |
| Root cause | Device Design |
| Action | On 12/30/2020, Zimmer Biomet issued an Urgent Medical Device Recall to the consumer/user level, including any intermediate wholesale or retail consignees. All distributors will be notified via email. Hospital risk managers and surgeons, as well as distributors with product, will be notified via courier. |
| Quantity | 174 systems |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173767 | A. L. P. S. Clavicle Plating System Biomet, Inc., Apr 6, 2018 |