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U.S. Department of Health and Human Services

Class 2 Device Recall EasyFuse

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  Class 2 Device Recall EasyFuse see related information
Date Initiated by Firm March 10, 2022
Create Date March 31, 2022
Recall Status1 Open3, Classified
Recall Number Z-0853-2022
Recall Event ID 89739
510(K)Number K203832  
Product Classification Staple, fixation, bone - Product Code JDR
Product EasyFuse Dynamic Compression System Instrument Pack
Code Information Model Number FFSP1530, UDI: 00889797103565  Lot Codes (Expiration Date): 781853-110321 (11/03/2029) and 780395-112221 (12/03/2029)
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
1023 Cherry Rd
Memphis TN 38117-5423
For Additional Information Contact Meghan Wells
901-201-9298
Manufacturer Reason
for Recall		 The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
FDA Determined
Cause 2		 Device Design
Action A recall notice was disseminated to the distributor and sales representatives via email (09-Mar-2022 and 10-Mar-2022) and to the hospitals via mail (10-Mar-2022, FedEx Priority Overnight). The hospital letters were delivered on 11-Mar-2022. Customers were instructed to immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility and remove them from their point of use. They are to return the enclosed business reply form by email to confirm receipt of the notification/document product segregation. Upon receipt of the completed business reply form, Stryker will arrange for the return and replacement of the product(s). Effectiveness checks will be performed through the confirmation of the returned/signed acknowledgement form.
Quantity in Commerce 176 packs
Distribution US distribution to Florida, North Carolina, Ohio, and Texas
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 = JDR and Original Applicant = Wright Medical
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