Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Stratum Foot Plating System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Stratum Foot Plating Systemsee related information
Date Initiated by FirmDecember 16, 2019
Create DateFebruary 11, 2020
Recall Status1 Terminated 3 on September 08, 2020
Recall NumberZ-1127-2020
Recall Event ID 84694
510(K)NumberK182201 
Product Classification Plate, fixation, bone - Product Code HRS
ProductStratum 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
FEI Number 3009540749
Recalling Firm/
Manufacturer		 Nextremity Solutions
6210 N Buffalo St
Warsaw IN 46580
For Additional Information Contact
732-683-9305
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
ActionOn 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 Commerce40
DistributionDomestic 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 CycleTPLC 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) Database510(K)s with Product Code = HRS
-
-