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Terminated

CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use.

FDA Recall Z-1496-2015 · Posted 2015-04-22

Recalling FirmWright Medical Technology, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2015-03-06
Date Terminated2018-08-05
Product Quantity372 units

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132594CROSSCHECK PLATING SYSTEMSolana Surgical, LLC · 2013-12-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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