Z-2065-2015Class II

Oxford Femoral Drill Guide Lateral IM Adapter

Name: Z-2065-2015 Oxford Femoral Drill Guide Lateral IM Adapter
Creator: Biomet, Inc.
Published: 2015-06-03
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-06-03 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a... on 2015-06-03. FDA classified it as Class II and gives the reason as "Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2065-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-03
Posted: 2015-07-14
Terminated: 2016-03-15
Recalling firm: Zimmer GmbH
Product: Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Product code: HWT Template
Reason for recall: Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 6/3/2015 an "URGENT MEDICAL DEVICE RECALL NOTICE" letter was sent to the affected distributors with instructions for locating and returning the affected product. The recall letter included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in commerce: 18
Distribution: Worldwide Distribution - US Nationwide in the states of NC, IN, PA, OH and the country of the Netherlands.
Product codes and lots: Part Number: 32-423400 Lot Numbers: 238220, 664720,489620, 490930,021410, 507150

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2065-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2065-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-14

Product code HWT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)