Date Initiated by Firm |
November 11, 2019 |
Create Date |
January 03, 2020 |
Recall Status1 |
Terminated 3 on September 10, 2020 |
Recall Number |
Z-0778-2020 |
Recall Event ID |
84405 |
510(K)Number |
K182201
|
Product Classification |
Screw, fixation, bone - Product Code HWC
|
Product |
Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST |
Code Information |
Lot Number: M1268 UDI: 00817701023173 |
Recalling Firm/ Manufacturer |
Nextremity Solutions 6210 N Buffalo St Warsaw IN 46580
|
For Additional Information Contact |
732-683-9305
|
Manufacturer Reason for Recall |
Components 2mm shorter than indicated on the package label
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Nextremity Solutions issued Urgent Medical Device Recall letter on 11/11/19 stating reason for recall, health risk and action to take: do not use, quarantine and return to Zimmer Biomet representative who will remove product, Contact customer service at 574-371-3071 between 8am -5pm(EST) M-F. |
Quantity in Commerce |
86 units |
Distribution |
Nationwide |
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 = HWC and Original Applicant = Nextremity Solutions, Inc.
|