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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 17, 2020
Create Date May 28, 2020
Recall Status1 Terminated 3 on June 25, 2021
Recall Number Z-2148-2020
Recall Event ID 85524
510(K)Number K133940  
Product Classification Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
Product 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
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    
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall
Potential presence of elevated endotoxin levels that exceed the specification limit
FDA Determined
Cause 2
Process control
Action Zimmer 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 from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. This form must be returned even if you do not have affected products available to return in your territory. b. For international returns, request an IRA by emailing zimmerbiometintlirarequests@zimmerbiomet.com c. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. CF04107 Rev. 4, Eff. Date: 16 Jul 2019 Ref. CP04102 Field Action Activities d. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. e. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeons that have already been notified of this recall. b. Identify whether there are any additional hospitals and/or surgeons that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts or surgeons to notify, please indicate that there are no additional accounts, or i
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRY and Original Applicant = BIOMET UK LTD.
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