Z-0227-2013Class II

Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem

Name: Z-0227-2013 Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem
Creator: Zimmer, Inc.
Published: 2012-09-04
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-09-04 / Terminated / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem on 2012-09-04. FDA classified it as Class II and gives the reason as "Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy...". 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-0227-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-04
Posted: 2012-11-06
Terminated: 2014-04-16
Recalling firm: Zimmer GmbH
Product: Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.
Quantity in commerce: 45 USA
Distribution: Nationwide Distribution.
Product codes and lots: REF Numbers: 01.04215.072, 01.04215.092, 01.04215.122, 01.04215.142. , 01.04217.072, 01.04217.132 Lot 2398402, 2485014, 2347028, 2347028, 2380422, 2348099, 2341901, 2435527, 2398475

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0227-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0210-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0211-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0212-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0213-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0214-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0215-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0216-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0217-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0218-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0219-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0220-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0221-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0222-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0223-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0224-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0225-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0226-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0227-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0228-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0229-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0230-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0231-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0232-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0233-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0234-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0235-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0236-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0237-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0238-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0239-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0240-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0241-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0242-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0243-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0244-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0245-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0246-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0247-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0248-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0249-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06

Product code KWS

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)