RecallRadar

FDA Device recall Z-0202-2015

GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement

On 2014-11-19 the FDA classified a Class II recall of GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement by Medacta Usa, citing medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0202-2015
ClassificationClass II
Statusterminated
Initiated2014-09-22
Published2014-11-19
Last updated2026-09-13 11:53 UTC
CompanyMedacta Usa
DistributionOH

Product

GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.

Reason

Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.

Identifiers

code_infoModel Number: 02.07.10.0162

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-0202-2015%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.