| Class 2 Device Recall | |
Date Initiated by Firm | April 17, 2020 |
Create Date | May 28, 2020 |
Recall Status1 |
Terminated 3 on June 25, 2021 |
Recall Number | Z-2146-2020 |
Recall Event ID |
85524 |
510(K)Number | K083782 |
Product Classification |
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
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Product | Knee Products:
141356 Regenerex Series-A Patella 3 Peg, 31 MM
141358 Regenerex Series-A Patella 3 Peg, 37 MM
Product Usage: Knee prosthesis |
Code Information |
Lot Numbers: UDI Number 1) 561760 (01)00880304554412(17)211229(10)561760; 2) 091090 (01)00880304506084(17)211214(10)091090 |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
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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 | 15 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 |
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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.
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510(K) Database | 510(K)s with Product Code = MBH
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