CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.
FDA device recall Z-1494-2015 · posted 2015-04-22 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology, Inc.
- 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
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 233 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-03-06
- Date posted
- 2015-04-22
- Date terminated
- 2018-08-05
- Location
- Memphis, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CROSSCHECK PLATING SYSTEM (K132594) | Solana Surgical, LLC | 2013-12-13 |