Recall Z-1485-2015
Wright Medical Technology, Inc. · initiated March 6, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use.
Codes / lots: Lot Numbers: 35049-31A-1, 35049-3A, 35049-3A-1-1, 362812, 36281-2-1
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
FDA-determined 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.
Details
- Recall number
- Z-1485-2015
- Initiated
- March 6, 2015
- Posted by FDA
- April 22, 2015
- Terminated
- August 5, 2018
- Product code
- HRS – Plate, Fixation, Bone
- Quantity
- 102 units
- Distribution
- Nationwide Distribution.
- Recalling firm
- Wright Medical Technology, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1482-2015 Class II | CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1483-2015 Class II | CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1484-2015 Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L. Orthopedic…The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1486-2015 Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L.…The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1487-2015 Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R.…The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1488-2015 Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L.…The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1489-2015 Class II | CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2R.…The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1490-2015 Class II | CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1491-2015 Class II | CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1492-2015 Class II | CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1493-2015 Class II | CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1494-2015 Class II | CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1495-2015 Class II | CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1496-2015 Class II | CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1497-2015 Class II | CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1498-2015 Class II | CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1499-2015 Class II | CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1500-2015 Class II | CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |