Date Initiated by Firm | November 11, 2019 |
Create Date | January 03, 2020 |
Recall Status1 |
Terminated 3 on September 10, 2020 |
Recall Number | Z-0777-2020 |
Recall Event ID |
84405 |
510(K)Number | K182201 |
Product Classification |
Screw, fixation, bone - Product Code HWC
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Product | Stratum MDS Screw 3.5x48mm ST
Part Number: STRM-MDS-3548ST |
Code Information |
Lot Number: M1267 UDI: 00817701023166 |
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 |
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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 = HWC
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