RecallRadar

FDA Device recall Z-1032-2017

Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6

On 2017-01-25 the FDA classified a Class II recall of Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6 by Exactech, citing products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1032-2017
ClassificationClass II
Statusterminated
Initiated2016-11-07
Published2017-01-25
Last updated2026-09-13 11:54 UTC
CompanyExactech
DistributionAZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, VA

Product

Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6

Reason

Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

Identifiers

code_info
Serial No. 3787445-3787447, 3868023-3868072, 4209114-4209135, 4318092-4318102, 4350860-4350869, 4386939, 4420620-442064…Serial No. 3787445-3787447, 3868023-3868072, 4209114-4209135, 4318092-4318102, 4350860-4350869, 4386939, 4420620-4420644, 4558261-4458262; Catalog No. 162-00-06; UDI: 10885862262776

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-1032-2017%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.