Z-1538-2018Class II

Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal...

Name: Z-1538-2018 Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal...
Creator: Zimmer Biomet, Inc.
Published: 2018-04-02
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-04-02 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The... on 2018-04-02. FDA classified it as Class II and gives the reason as "Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1538-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-02
Posted: 2018-04-27
Terminated: 2020-05-12
Recalling firm: Zimmer GmbH
Product: Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 4/2/2018 to its customers. The letter described the product, problem and actions to be taken. Distributors will be notified of the recall via email. Hospital risk managers and distributors with product will be notified via courier. The distributor letter includes instructions to locate and remove the product in their territory, identify hospitals who have previously used the product; return on-hand product to the recalling firm and ensure all products are accounted for. The letter for hospital risk managers instruct the risk managers to assist the recalling firm's sales reps with quarantine of the product; to review notification and ensure affected personnel are aware of the contents; and complete and return the Certificate of Acknowledgement form to [email protected], even if you do not have product, and retain a copy. Customers with questions are directed to call customer service at 574-371-3071 between 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to [email protected].
Quantity in commerce: 18
Distribution: Worldwide Distribution: US (nationwide) in states of: AL, AR, FL, GA, IN, KY, LA, MO, MS, OH, OK, TX, and VA; and countries of: Canada, Costa Rica and Chile.
Product codes and lots: lot 299340

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1538-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1537-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-27
Z-1538-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-27

Product code LPH

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)