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U.S. Department of Health and Human Services

Class 2 Device Recall Norian Drillable Injects Sterile

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  Class 2 Device Recall Norian Drillable Injects Sterile see related information
Date Initiated by Firm May 11, 2016
Date Posted June 09, 2016
Recall Status1 Terminated 3 on March 10, 2017
Recall Number Z-1943-2016
Recall Event ID 74172
510(K)Number K102722  K073303  
Product Classification Filler, bone void, calcium compound - Product Code MQV
Product Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S
Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
Code Information Catalog ID 07.704.003S, 07.704.005S and 07.704.010S Lot Numbers: DSC1679, DSC3869, DSC7712, DSC8448, DSC9141, DSD0256, DSD2012, DSD2506, DSD3236, DSC1747, DSC1748, DSC2468, DSC3590, DSC3874, DSC6847, DSC7713, DSC8449, DSC9067, DSC9142, DSD0257, DSD0919, DSD2013, DSD2380, DSD3237. DSC1676, DSC2469, DSC3591, DSC3879, DSC8441, DSC9143, DSD0055, DSD0466, DSD1956, DSD2381
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact Ann Brisson
610-719-6561
Manufacturer Reason
for Recall		 DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.
FDA Determined
Cause 2		 Under Investigation by firm
Action DePuy Synthes sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected products were asked to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s), Complete the Verification Section (page 3 of this letter) and Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section by:Fax: 855-695-8597 or Scan/email: Synthes6797@stericycle.com. If they had any questions they were asked to call 610-719-5450. For questions regarding this recall call 610-719-5443.
Quantity in Commerce 2812 units
Distribution Worldwide Distribution - Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada...
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 = MQV and Original Applicant = SYNTHES (USA)
510(K)s with Product Code = MQV and Original Applicant = SYNTHES USA PRODUCTS LLC
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