Z-0980-2018Class II

Humeral Stem 55mm(Size 13)

Name: Z-0980-2018 Humeral Stem 55mm(Size 13)
Creator: Zimmer Biomet, Inc.
Published: 2017-12-08
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-12-08 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty on 2017-12-08. FDA classified it as Class II and gives the reason as "Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference...". 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-0980-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-08
Posted: 2018-03-13
Terminated: 2018-09-04
Recalling firm: Zimmer GmbH
Product: Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Product code: HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Reason for recall: Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On December 13, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers notifying them of the mix-up and requesting that they review the notification, discuss with team members, see if any product is in inventory and if so, quarantine and discontinue use. Affected product should be returned to the recalling firm. Questions or concerns can be directed to customer service at 574-371-3071.
Quantity in commerce: 12
Distribution: US Nationwide in the states of MN, NJ, CA, TX, ND
Product codes and lots: PN: 113617, LN: 552850, UDI# - (01) 00880304554184 (17) 271014 (10) 552850

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0980-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0979-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0980-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13

Product code HSD

K060692Class IIComprehensive Primary Shoulder StemsBiomet Manufacturing Corp / cleared 2006-05-30

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)