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U.S. Department of Health and Human Services

Class 2 Device Recall 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws

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 Class 2 Device Recall 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screwssee related information
Date Initiated by FirmMay 13, 2015
Date PostedJune 15, 2015
Recall Status1 Terminated 3 on August 18, 2016
Recall NumberZ-1800-2015
Recall Event ID 71276
510(K)NumberK000684 K050683 
Product Classification Screw, fixation, bone - Product Code HWC
Product3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.
Code Information Part Numbers: 02.240.044, 02.240.244, Lot Numbers 8886011, 8886046 
FEI Number 3005180112
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information ContactCustomer Support
610-719-5000
Manufacturer Reason
for Recall		Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.
FDA Determined
Cause 2		Employee error
ActionDePuy Synthes sent an Urgent Notice Medical Device Recall letter dated May 13, 2015, to all affected customers to advise them about the issue and associated risks. These accounts were asked to review inventory, immediately remove the affected lots that are still in the original packaging from stock, and to complete and return the response and return authorization forms. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes consultant.
Quantity in Commerce54
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HWC
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