ClearanceBrief
Recall Z-2148-2020 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Biomet, Inc.

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

DateApr 17, 2020
StatusTerminated
ReasonPotential presence of elevated endotoxin levels that exceed the specification limit
Root causeProcess control
ActionZimmer Biomet issued Urgent Medical Device recall letter dated April 17, 2002 to distributors with direct sales and/or field inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory, as well as hospitals that have consumed products will be notified via FedEx. Surgeons that have consumed products will be notified via FedEx. Action to take: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product
Quantity76 units
DistributionWorldwide 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,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K133940OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
Biomet UK, Ltd., Mar 28, 2014