Z-0298-2018Class II

COMP 12MM HUM FRAC STEM MACRO, model # 11-113562

Name: Z-0298-2018 COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
Creator: Zimmer Biomet, Inc.
Published: 2017-06-05
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-06-05 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of COMP 12MM HUM FRAC STEM MACRO, model # 11-113562 on 2017-06-05. FDA classified it as Class II and gives the reason as "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". 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-0298-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-05
Posted: 2017-12-29
Terminated: 2018-03-06
Recalling firm: Zimmer GmbH
Product: COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
Product code: KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: On June 5, 2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers via email and Fed Ex courier service. ***Risk Managers are advised to: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative to quarantine all affected product. 3. Work with your Zimmer Biomet sales representative in removing the affected product from your facility. 4. Confirm that the patient labels in your records are correct. 5. Complete the Certificate of Acknowledgement and return a digital copy to [email protected] and retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilities documentation. ****Distributors, Sales Reps & Distributor Operation Managers are advised to: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form and return a digital copy to [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet. a. Request a Recall Return Authorization Number via SMS or via email to [email protected] (domestic) or via email to [email protected] (international). b. For each return, send a copy of Attachment 1 to [email protected]. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Mark the outside of the returns box(es) clearly with RECALL. Customers with further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5
Distribution: Nationwide in US; Internationally Argentina, Netherlands & Canada
Product codes and lots: Lot Number: 529890

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0298-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0296-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2017-12-29
Z-0297-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2017-12-29
Z-0298-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2017-12-29
Z-0299-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2017-12-29
Z-0300-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2017-12-29
Z-0301-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2017-12-29
Z-0302-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2017-12-29
Z-0303-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2017-12-29
Z-0304-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2017-12-29
Z-0305-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2017-12-29

Product code KWT

K023063Class IIComprehensive Humeral Fracture SystemBiomet Orthopedics, Inc. / cleared 2002-12-13

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)