Date Initiated by Firm | August 10, 2017 |
Create Date | February 15, 2018 |
Recall Status1 |
Terminated 3 on September 10, 2018 |
Recall Number | Z-0617-2018 |
Recall Event ID |
79043 |
510(K)Number | K102722 |
Product Classification |
Calcium salt bone void filler, drillable, non-screw augmentation - Product Code OIS
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Product | Norian 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
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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 |
Action | On 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 Commerce | 239 units |
Distribution | Nationwide Distribution. |
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 = OIS
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