CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.
- Company
- Wright Medical Technology, Inc.
- Recall Initiated
- March 6, 2015
- Posted
- April 22, 2015
- Terminated
- August 5, 2018
- Recall Number
- Z-1494-2015
- Quantity
- 233 units
- Firm Location
- Memphis, TN
Reason for Recall
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Distribution
Nationwide Distribution.
Lot / Code Info
Lot Numbers: 3504927, 35049-27A, 35049-27A-1, 35049-28, 362801, 36280-1-1, 8752-010381
Root Cause
Nonconforming Material/Component
Action Taken
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.