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U.S. Department of Health and Human Services

Class 2 Device Recall HydroSet XT Injectable HA Bone Cement

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 Class 2 Device Recall HydroSet XT Injectable HA Bone Cementsee related information
Date Initiated by FirmNovember 15, 2018
Create DateDecember 22, 2018
Recall Status1 Terminated 3 on June 18, 2020
Recall NumberZ-0677-2019
Recall Event ID 81641
510(K)NumberK161447 
Product Classification Filler, bone void, calcium compound - Product Code MQV
ProductHydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
Code Information UDI - (01)07613327064261 Lot Numbers: IC02565, ICO2570
FEI Number 3004024955
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information ContactChrista Joisil
201-760-8000
Manufacturer Reason
for Recall		Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19
FDA Determined
Cause 2		Labeling mix-ups
ActionOn November 15, 2018, Stryker issued Urgent Medical Device Recall notices to customers via Fedex. Customers were advised to take the following actions: 1. Inform users of the medical device recall and forward a copy of the notice to all those individuals who need to be aware within the organization. 2. Examine inventory to identify impacted HydroSet kits. 3. Immediately quarantine any affected product. 4. Complete and return the Business Reply Form via email to Strykerortho6629@stericycle.com or via fax to 1-888-345-3845. 5. Return all affected product available at your location to the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive, Dock M-East, Mahwah, NJ 07431, Ref. PFA 1878253
DistributionCO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV
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 = MQV
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