Z-1008-2018Class II

36Mm Cocr Modular Hd -6Mm

Name: Z-1008-2018 36Mm Cocr Modular Hd -6Mm
Creator: Zimmer Biomet, Inc.
Published: 2017-09-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-09-15 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of 36MM COCR MODULAR HD -6MM on 2017-09-15. FDA classified it as Class II and gives the reason as "One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the...". 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-1008-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-15
Posted: 2018-03-14
Terminated: 2018-08-20
Recalling firm: Zimmer GmbH
Product: 36Mm Cocr Modular Hd -6Mm
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Foreign risk managers were emailed notification of recall with the following instructions: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 23
Distribution: Outside USA
Product codes and lots: 11-363660 UDI Number: (01) 00880304210509 (17) 270507 (10) 236840 Product Number: 11-363660 Lot Number: 236840

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1008-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1008-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14

Product code JDI

K032396Class IIRingloc 36Mm Line and Modular Femoral HeadsBiomet, Inc. / cleared 2003-08-21

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)