Knee Products: 154335 Oxford recall: Endotoxin
Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral…
Why was Knee Products: 154335 Oxford recalled?
Potential presence of elevated endotoxin levels that exceed the specification limit
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral…
- Recalling firm
- Biomet, Inc.
- Quantity
- 76 units
- Distribution
- 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.
- Recall date
- June 3, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)