Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented...
FDA Device Recall #Z-2148-2020 — Class II — April 17, 2020
Recall Summary
| Recall Number | Z-2148-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 17, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Biomet, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | 76 units |
Product Description
Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7 154355 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, B3 154361 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, C4 154366 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, D4 154370 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, E3 154375 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 154375 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 154376 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4 154376 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4 154377 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F5 159575 Oxford Partial Knee System Anatomic Meniscal Bearing, Right Medial, Medium, 3 MM Product Usage: Knee prosthesis
Reason for Recall
Potential presence of elevated endotoxin levels that exceed the specification limit
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.
Lot / Code Information
Lot Numbers: Product UDI Number 666130 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 (01)05019279515226(17)211226(10)666130 570480 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 (01)05019279515240(17)211223(10)570480 589030 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7 (01)05019279515301(17)211226(10)589030 602820 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, B3 (01)05019279515493(17)211226(10)602820 328350 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, E3 (01)05019279515646(17)211223(10)328350 560530 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 (01)05019279999453(17)211226(10)560530 827910 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 (01)05019279999453(17)211224(10)827910 786780 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4 (01)05019279999460(17)211226(10)786780 602860 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F5 (01)05019279999477(17)211223(10)602860 374340 Knees Oxford Partial Knee System Anatomic Meniscal Bearing, Right Medial, Medium, 3 MM (01)05019279786213(17)211228(10)374340 374340 Oxford Partial Knee System Anatomic Meniscal Bearing, Right Medial, Medium, 3 MM (01)05019279786213(17)211228(10)374340
Other Recalls from Biomet, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0212-2026 | Class II | BIOMET ZipTight, Acute AC Joint Implant, Single... | Sep 23, 2025 |
| Z-2619-2025 | Class II | Juggerknot Mini Soft Anchors, Model/Catalog Num... | Sep 9, 2025 |
| Z-0477-2025 | Class II | JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model nu... | Oct 21, 2024 |
| Z-2179-2024 | Class II | RingLoc Bi-Polar Hip System Acetabular Cup, 41 ... | May 17, 2024 |
| Z-1607-2024 | Class II | Vanguard Knee System AS Tibial Bearing / DCM Ar... | Mar 13, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.