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U.S. Department of Health and Human Services

Class 2 Device Recall Affixus Intramedullary Hip Fracture Nail

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  Class 2 Device Recall Affixus Intramedullary Hip Fracture Nail see related information
Date Initiated by Firm August 07, 2017
Create Date January 29, 2018
Recall Status1 Terminated 3 on March 29, 2019
Recall Number Z-0424-2018
Recall Event ID 78763
510(K)Number K100238  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM
Code Information Item No. 814411320; Lot No. (Exp. Date) UDI: 459230 (05/19/2027) UDI (01)00887868038464 (17)270519 (10)459230, 701830 (06/03/2027) UDI (01)00887868038464 (17)270603 (10)701830, 893480 (06/12/2027) UDI (01) 00887868038464 (17)270612 (10)893480
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-371-3071
Manufacturer Reason
for Recall		 During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
FDA Determined
Cause 2		 Process change control
Action Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.
Quantity in Commerce 638 units
Distribution US nationwide distribution. Also Portugal and the Netherlands.
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 = HSB and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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