RecallRadar

FDA Device recall Z-0977-2015

lnline Persuader- PedFuse Pedicle Screw System

On 2015-01-21 the FDA classified a Class II recall of lnline Persuader- PedFuse Pedicle Screw System by Spinefrontier, citing A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0977-2015
ClassificationClass II
Statusterminated
Initiated2014-12-19
Published2015-01-21
Last updated2026-09-13 11:53 UTC
CompanySpinefrontier
DistributionUS

Product

lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164

Reason

A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.

Identifiers

code_infoLot/Serial Numbers: 06440-0000, 06441-0000, AG24

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-0977-2015%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.