Recall Z-1489-2015 ยท HRS Plate, Fixation, Bone
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2R. Orthopedic use.
| Date | Apr 22, 2015 (initiated Mar 6, 2015) |
| Status | Terminated |
| Reason | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction |
| Root cause | Nonconforming Material/Component |
| Action | Firm has initiated the recall on 03/06/2015 through written communication via Fed Ex P1 delivery to all Wright Medical Technologies distributors (hubs). Follow-up to non-responding consignees will commence 30 days after initiation. Effectiveness checks will be performed through the confirmation of returned product via a validated ERP system, a returned/signed verification form, and in the case of non-responders, a phone call, e-mail or follow up letter, depending on the region and availability of consignee. |
| Quantity | 242 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132594 | CROSSCHECK PLATING SYSTEM Solana Surgical, LLC, Dec 13, 2013 |