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U.S. Department of Health and Human Services

Class 2 Device Recall Norian Drillable

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 Class 2 Device Recall Norian Drillablesee related information
Date Initiated by FirmAugust 10, 2017
Create DateFebruary 15, 2018
Recall Status1 Terminated 3 on September 10, 2018
Recall NumberZ-0617-2018
Recall Event ID 79043
510(K)NumberK102722 
Product Classification Calcium salt bone void filler, drillable, non-screw augmentation - Product Code OIS
ProductNorian Drillable Inject
Code Information Product Number: 07.704.003S Lot Number: DSD9110
Recalling Firm/
Manufacturer		 Synthes USA
1230 Wilson Dr
West Chester PA 19380-4231
For Additional Information Contact
484-356-9500
Manufacturer Reason
for Recall		The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.
FDA Determined
Cause 2		Process control
ActionOn August 15, 2017 an Urgent Medical Device Recall notice, titled "895204 NORIAN DRILLABLE INJECT" was issued to customers instructing them to review inventory and quarantine all affected product subject to the recall. For questions. concerns or to obtain a return authorization Call 1-800-479-6329. Returned product will be credited.
Quantity in Commerce239 units
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 = OIS
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