Z-1496-2015Class II
CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use
Wright Medical Technology Inc / initiated 2015-03-06 / Terminated / root cause: manufacturing process
Wright Medical Technology, Inc. began a recall of CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use on . FDA classified it as Class II and gives the reason as "The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1496-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Wright Medical Technology Inc
- Product
- CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use.
- Product code
- HRS Plate, Fixation, Bone
- 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
- Root cause tag
- manufacturing process
- FDA 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 in commerce
- 372 units
- Distribution
- Nationwide Distribution.
- Product codes and lots
- Lot Numbers: 3504931, 35049-31A, 35049-31A-1, 35049-32, 362803, 36280-3-1, 8752-010381
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1482-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1483-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1484-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1485-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1486-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1487-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1488-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1489-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1490-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1491-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1492-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1493-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1494-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1495-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1496-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1497-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1498-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1499-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1500-2015 | Class II | Terminated | Voluntary: Firm initiated |
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