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U.S. Department of Health and Human Services

Class 2 Device Recall InjectionPlasty 1.0

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  Class 2 Device Recall InjectionPlasty 1.0 see related information
Date Initiated by Firm May 29, 2015
Date Posted July 24, 2015
Recall Status1 Terminated 3 on July 24, 2015
Recall Number Z-2209-2015
Recall Event ID 71459
510(K)Number K051123  
Product Classification Filler, bone void, calcium compound - Product Code MQV
Product InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary components for mixing and delivery of the bone void filler. The InjectionPlasty 1.0 sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, a Mixing System, Targeting K-Wires and a Delivery Needle (Cannula).
Model number 10801210.

InjectionPlasty 1.0 is indicated to fill bony voids or gaps of the skeletal system
Code Information Model number: 10801210: Lot Numbers Expiration Dates  13022501 8/31/2015 13052305 11/30/2015 13120901 5/31/2016 14051901 11/30/2016 14100101 3/31/2017 15042701 10/13/2017 
Recalling Firm/
Manufacturer		 Skeletal Kinetics, Llc
10201 Bubb Rd
Cupertino CA 95014-4167
For Additional Information Contact Duran Yetkinler, M.D.
408-366-5002
Manufacturer Reason
for Recall		 Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.
FDA Determined
Cause 2		 No Marketing Application
Action Skeletal Kinetics sent letters to distributors by overnight mail with instructions to forward a Dear Doctor notification letter on May 14, 2015. Second letters dated May 29, 2015, advised that the firm is removing the product from the marker. Distributor letters asked that the Dear Doctor letter be forward within 24 hours of receipt of the letter. All Injection Plasty kits in their possession and those with customers should be retrieved and returned by Fed Ex. Dear Doctor letters advised that their distribution agent has been requested to return all unused kits. Questions may be directed to 408-366-5002 of duran@skeletalkinetics.com.
Quantity in Commerce 67 kits
Distribution US Distribution including Puerto Rico.
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 = SKELETAL KINETICS, LLC
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