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U.S. Department of Health and Human Services

Class 2 Device Recall CROSSCHECK(R) Plating system, Utility Plate, 5Hole, REF CCPUTN5

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  Class 2 Device Recall CROSSCHECK(R) Plating system, Utility Plate, 5Hole, REF CCPUTN5 see related information
Date Initiated by Firm March 06, 2015
Date Posted April 22, 2015
Recall Status1 Terminated 3 on August 05, 2018
Recall Number Z-1497-2015
Recall Event ID 70859
510(K)Number K132594  
Product Classification Plate, fixation, bone - Product Code HRS
Product CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5.

Orthopedic use.
Code Information Lot Numbers: 3504933, 35049-33A, 35049-33A-1, 35049-34, 362804, 36280-4-1-A
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
1023 Cherry Rd
Memphis TN 38117-5423
For Additional Information Contact Amanda Clark, PhD
901-290-5662
Manufacturer 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 2		 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 138 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = SOLANA SURGICAL, LLC
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