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U.S. Department of Health and Human Services

Class 2 Device Recall Fx SOLUTIONS CENTERED HEAD

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 Class 2 Device Recall Fx SOLUTIONS CENTERED HEADsee related information
Date Initiated by FirmJune 04, 2018
Create DateJuly 17, 2018
Recall Status1 Terminated 3 on April 05, 2019
Recall NumberZ-2468-2018
Recall Event ID 80302
510(K)NumberK111097 
Product Classification Prosthesis, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
ProductFx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Code Information UDI: 03701037300435 Lot Numbers:  K238, K240, K689R, K1119, K1120, K1121, K1844, L1730, L1737, L1748, L1756, L1764, L1820, M1042 OUS only: K237, K239
FEI Number 3009532798
Recalling Firm/
Manufacturer		 Fx Solutions
1663 Rue de Majornas
Viriat Rhone-Alpes France
Manufacturer Reason
for Recall		Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
FDA Determined
Cause 2		Package design/selection
ActionThe firm initiated the recall by email on 06/04/2018 in France, on 06/05/2018, to distributors in the US and elsewhere. The distributor (US Agent) sent the notice on to the division agents who store the product. The firm requested return of the units.
Quantity in Commerce131 units
DistributionWorldwide Distribution - US Nationwide and the countries of: France, Argentina, South Africa, Spain, Israel, Germany, Lebanon, Italy, Chile, Belgium, Greece, Mexico, Poland, Hong Kong, Switzerland
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 = HSD
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