RecallRadar

FDA Device recall Z-0662-2016

Excella II Rod Cat

On 2016-01-27 the FDA classified a Class II recall of Excella II Rod Cat by Innovasis, citing innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0662-2016
ClassificationClass II
Statusterminated
Initiated2015-12-07
Published2016-01-27
Last updated2026-09-13 11:54 UTC
CompanyInnovasis
DistributionCA, KS, OH, TX

Product

Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.

Reason

Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.

Identifiers

code_infoCatalog No.: SR55110 Lot 1502 and SR55100 Lot 1502

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0662-2016%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.