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U.S. Department of Health and Human Services

Class 2 Device Recall Stratum Foot Plating System

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  Class 2 Device Recall Stratum Foot Plating System see related information
Date Initiated by Firm December 16, 2019
Create Date February 11, 2020
Recall Status1 Terminated 3 on September 08, 2020
Recall Number Z-1127-2020
Recall Event ID 84694
510(K)Number K182201  
Product Classification Plate, fixation, bone - Product Code HRS
Product Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
Code Information Lot M1502
Recalling Firm/
Nextremity Solutions
6210 N Buffalo St
Warsaw IN 46580
For Additional Information Contact
Manufacturer Reason
for Recall
The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
FDA Determined
Cause 2
Under Investigation by firm
Action On December 16, 2019, the firm notified customers and distributors via recall notification letter and e-mail. The notification instructed return of all product with the specified lot number. If customers have any questions, please call customer service at 574-371-3071 between 8AM-5PM EST, Monday thru Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 40
Distribution Domestic distribution to AL, CA, FL, GA, ID, IL, IA, KY, LA, ME, MA, MI, MN, MS, NE, NJ, NY, OH ,OK, OR, TX, and WA.
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.