FDA Medical Device Recalls (openFDA)
Biomet, Inc.: 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.
- Recall number
- Z-2065-2015
- Recalling firm
- Biomet, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-06-03
- Posted
- 2015-07-14
- Terminated
- 2016-03-15
- Reason
- 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
- 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
- 18
- Distribution
- Worldwide Distribution - US Nationwide in the states of NC, IN, PA, OH and the country of the Netherlands.
- Lot, serial or model codes
- Part Number: 32-423400 Lot Numbers: 238220, 664720,489620, 490930,021410, 507150
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWT
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28