Date Initiated by Firm | November 01, 2016 |
Date Posted | December 01, 2016 |
Recall Status1 |
Terminated 3 on June 01, 2017 |
Recall Number | Z-0681-2017 |
Recall Event ID |
75694 |
510(K)Number | K043310 |
Product Classification |
Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
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Product | Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm
Non-Sterile |
Code Information |
Model/Catalog # 316.15 Lot/Serial Number U172728 |
Recalling Firm/ Manufacturer |
Synthes (USA) Products LLC 1301 Goshen Pkwy West Chester PA 19380-5986
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Manufacturer Reason for Recall | Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | DePuy Synthes sent an Urgent Notice to customers affected by the recall to inform them of the potential impacts, and actions to be taken for the return of the identified units. |
Quantity in Commerce | 84 units |
Distribution | Distributed 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 = HWE
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