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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71459

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 29, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Skeletal Kinetics, Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2209-2015
Recall number
Z-2209-2015
Initiated
May 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Skeletal Kinetics, Llc
Quantity
67 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

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Inspect official wording and provenance

Reason for recall

Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.

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

Distribution pattern

US Distribution including Puerto Rico.

Field note

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