Z-0992-2018Class II

Delta Cer Fem Hd 32/0Mm T1

Name: Z-0992-2018 Delta Cer Fem Hd 32/0Mm T1
Creator: Zimmer Biomet, Inc.
Published: 2017-06-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-06-30 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty on 2017-06-30. FDA classified it as Class II and gives the reason as "Product may contain the presence of melted sterile packaging upon opening". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0992-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-30
Posted: 2018-03-14
Terminated: 2018-04-13
Recalling firm: Zimmer GmbH
Product: DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Product may contain the presence of melted sterile packaging upon opening.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On June 2, 2017 an URGENT Medical Recall Letter was issued to customers regarding affected product(s). The letter requests customers to review the content and notify affected personnel of the recall. Assist the sales representative in quarantining affected product, which will be removed and returned to recalling firm and then replaced. All customers who may have received product from distributors are to be notified. Questions or concerns can be directed to 1-574-372-4847.
Quantity in commerce: 30
Distribution: US in the state of Texas
Product codes and lots: part number: 650-1162 lot number: 2016030466

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0992-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0992-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0993-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13

Product code LZO

K131684Class IIBiolox(r) Delta Ceramic HeadsBiomet, Inc. / cleared 2013-10-10

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)