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Class 2 Device Recall Stratum Foot Plating System |
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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
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Product Classification |
Plate, fixation, bone - Product Code HRS
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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/ Manufacturer |
Nextremity Solutions 6210 N Buffalo St Warsaw IN 46580
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For Additional Information Contact |
732-683-9305
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = HRS and Original Applicant = Nextremity Solutions, Inc.
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