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U.S. Department of Health and Human Services

Class 2 Device Recall CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCPLPX1R

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  Class 2 Device Recall CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCPLPX1R 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-1487-2015
Recall Event ID 70859
510(K)Number K132594  
Product Classification Plate, fixation, bone - Product Code HRS
Product CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R.

Orthopedic use.
Code Information Lot Numbers: 35049-7A, 35049-7A-1, 362832, 36283-2-2
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 142 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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