Z-2209-2015Class II

InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler...

Name: Z-2209-2015 InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler...
Creator: Skeletal Kinetics, Llc
Published: 2015-05-29
License: https://open.fda.gov/license/

Skeletal Kinetics, LLC / initiated 2015-05-29 / Terminated

FDA source

Skeletal Kinetics, Llc began a recall of InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use... on 2015-05-29. FDA classified it as Class II and gives the reason as "Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2209-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Posted: 2015-07-24
Terminated: 2015-07-24
Recalling firm: Skeletal Kinetics, LLC
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
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.
FDA root cause: 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 [email protected].
Quantity in commerce: 67 kits
Distribution: US Distribution including Puerto Rico.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2209-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2209-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-24

Product code MQV

K051123Class IICallos Impact and Inject Bone Void FillerSkeletal Kinetics, LLC / cleared 2005-06-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)