RecallRadar

FDA Device recall Z-0302-2018

CER BIOLOXD OPTION HD 32MM, model # 650-1056

On 2018-01-10 the FDA classified a Class II recall of CER BIOLOXD OPTION HD 32MM, model # 650-1056 by Zimmer Biomet, citing possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label c….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0302-2018
ClassificationClass II
Statusterminated
Initiated2017-06-05
Published2018-01-10
Last updated2026-09-13 11:54 UTC
CompanyZimmer Biomet
DistributionUS

Product

CER BIOLOXD OPTION HD 32MM, model # 650-1056

Reason

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Identifiers

code_infoLot Number: 843260

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-0302-2018%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.