RecallRadar

FDA Device recall Z-2772-2015

Aliquot Delivery Kit (Syringe and Plunger)

On 2015-09-23 the FDA classified a Class II recall of Aliquot Delivery Kit (Syringe and Plunger) by Orthovita, citing two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2772-2015
ClassificationClass II
Statusterminated
Initiated2015-08-20
Published2015-09-23
Last updated2026-09-13 11:53 UTC
CompanyOrthovita
DistributionUS

Product

Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone

Reason

Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration

Identifiers

code_infoAll lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2772-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.