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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker CLAW II ORTHOLOC

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  Class 2 Device Recall Stryker CLAW II ORTHOLOC see related information
Date Initiated by Firm December 03, 2021
Create Date December 17, 2021
Recall Status1 Open3, Classified
Recall Number Z-0392-2022
Recall Event ID 89089
510(K)Number K113014  
Product Classification Plate, fixation, bone - Product Code HRS
Product Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.
Code Information Lot #1642103
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
11576 Memphis Arlington Rd
Arlington TN 38002-9497
For Additional Information Contact Ms. Meghan Wells
901-201-9298
Manufacturer Reason
for Recall		 The incorrect product is contained in the packaging.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued a recall letter dated 03 Dec 2021 on 12/3/2021 via Fed Ex Priority Overnight. The letter explained the packages labeled as the CLAW II 4 Hole Plates and the packages labeled as the DARCO Locking Screws were switched, resulting in the packages containing the incorrect product. The letter also provided the potential risks, the actions needed to be taken, and provided example labels of affected products. The consignee is to immediately check their inventory to locate the packaged product and remove them from their point of use. The enclosed business reply form was to be returned via email to confirm receipt of the letter and document product segregation. After the firm receives the reply form, the consignee will be contacted to arrange for return and replacement. The consignee was given the choice of providing subdistribution contact details to the recalling firm so the recalling firm could inform them of the recall, or the consignee can notify their downstream customers of the recall.
Quantity in Commerce 23 units
Distribution Worldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The countries of Canada, France, Germany, Lebanon, The Netherlands, Saudi Arabia, and United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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