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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 0.76 mm Drill Bit

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  Class 2 Device Recall Synthes 0.76 mm Drill Bit see related information
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
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
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
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 = HWE and Original Applicant = SYNTHES (USA)
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