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U.S. Department of Health and Human Services

Class 2 Device Recall Stratum

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  Class 2 Device Recall Stratum see related information
Date Initiated by Firm October 09, 2019
Create Date November 22, 2019
Recall Status1 Terminated 3 on June 24, 2020
Recall Number Z-0534-2020
Recall Event ID 84160
510(K)Number K182201  
Product Classification Plate, fixation, bone - Product Code HRS
Product Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile.
Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.
Code Information Lot Number: M1151 UDI: 00817701022558
Recalling Firm/
Manufacturer		 Nextremity Solutions
6210 N Buffalo St
Warsaw IN 46580
For Additional Information Contact
732-683-9305
Manufacturer Reason
for Recall		 Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
FDA Determined
Cause 2		 Labeling mix-ups
Action Nextremity Solutions issued Urgent Medical Device notification dated 10/09/19, identifying product, reason for recall, health risk and action to take: review inventory , quarantine for product for return and contact your Zimmer Biomet Rep. will remove product from your facility. Complete and return the Medical Device Response Form. Questions contact customer service 574-371-3071, 8 am-5pm, M-F (EST).
Quantity in Commerce 49 units
Distribution US 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 = Nextremity Solutions, Inc.
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