Z-1032-2017Class II

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

Name: Z-1032-2017 Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
Creator: Exactech, Inc.
Published: 2016-11-07
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2016-11-07 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6 on 2016-11-07. FDA classified it as Class II and gives the reason as "Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1032-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-07
Posted: 2017-01-17
Terminated: 2019-08-05
Recalling firm: Exactech, Inc.
Product: Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: In the recall notice sent to agents, dated 11/01/2016, recipients are instructed to cease product distribution, extend knowledge of the recall to their accounts, identify and quarantine any product in inventory, and complete and return the Recall Inventory Response Form. Consignees are instructed to contact their Exactech Representative within 5 days of receipt of the notice to confirm product quantities at each location. Consignees with any questions are instructed to contact Kaya Davis at [email protected] or 1-800-392-2832.
Quantity in commerce: 98
Distribution: AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
Product codes and lots: Serial No. 3787445-3787447, 3868023-3868072, 4209114-4209135, 4318092-4318102, 4350860-4350869, 4386939, 4420620-4420644, 4558261-4458262; Catalog No. 162-00-06; UDI: 10885862262776

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1032-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1030-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-17
Z-1031-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-17
Z-1032-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-17

Product code LZO

K141821Class IIAlteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving Femoral Stem, Extended OffsetExactech, Inc. / cleared 2014-08-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)