Date Initiated by Firm | July 21, 2017 |
Create Date | February 13, 2018 |
Recall Status1 |
Terminated 3 on July 10, 2018 |
Recall Number | Z-0604-2018 |
Recall Event ID |
78958 |
510(K)Number | K011857 |
Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
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Product | 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile |
Code Information |
Lot H302839, Expiration Date 31Jan2026 |
Recalling Firm/ Manufacturer |
Synthes (USA) Products LLC 1301 Goshen Pkwy West Chester PA 19380-5986
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Manufacturer Reason for Recall | The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot. |
FDA Determined Cause 2 | Employee error |
Action | The company issued a recall letter on 7/21/2017 asking customers to quarantine affected product and arrange for it to be returned. |
Quantity in Commerce | 4 units |
Distribution | TX, GA, PA, UT and Canada |
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 = HSB
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