FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189426 Vanguard Knee System, PS Mono Lock Tibial Bearing, 16 MM X 63 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM
- Recall number
- Z-2152-2020
- Recalling firm
- Biomet, Inc.
- Product
- Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189426 Vanguard Knee System, PS Mono Lock Tibial Bearing, 16 MM X 63 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM
- Status
- Terminated
- Initiated
- 2020-04-17
- Posted
- not on file
- Terminated
- 2021-06-25
- Reason
- Potential presence of elevated endotoxin levels that exceed the specification limit
- Root cause
- 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
- 107 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.
- Lot, serial or model codes
- Lot Numbers: UDI Number 530900 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)211223(10)530900 548950 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM (01)00880304451360(17)211222(10)548950 602870 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM (01)00880304451360(17)211228(10)602870 530930 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211223(10)530930 588890 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211223(10)588890 602930 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211228(10)602930 697510 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211227(10)697510 700830 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211228(10)700830 530940 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)211223(10)530940 758560 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)211228(10)758560 758580 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)211223(10)758580 884710 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)211229(10)884710 570620 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220106(10)570620 884680 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220107(10)884680 828010 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220106(10)828010 855380 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220111(10)855380 855390 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220111(10)855390 772740 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)220112(10)772740 796110 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)220115(10)796110 796120 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)220112(10)796120 796150 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220112(10)796150 828040 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220115(10)828040 830730 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220115(10)830730 727060 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)220121(10)727060 505430 Vanguard Knee System, PS Mono Lock Tibial Bearing, 16 MM X 63 MM (01)00880304454859(17)220125(10)505430 581950 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220121(10)581950 608380 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220118(10)608380 644080 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220118(10)644080 708620 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220121(10)708620 758570 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220118(10)758570
- 510(k) numbers
- ["K060525"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28