Z-2151-2020Class II
Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee...
Zimmer GmbH / initiated 2020-04-17 / Terminated / root cause: manufacturing process
Biomet, Inc. began a recall of Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83... on . FDA classified it as Class II and gives the reason as "Potential presence of elevated endotoxin levels that exceed the specification limit". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2151-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM 189704 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM Product Usage: Knee prosthesis
- Product code
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Reason for recall
- Potential presence of elevated endotoxin levels that exceed the specification limit
- Root cause tag
- manufacturing process
- FDA 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 [email protected] 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 [email protected] c. For each return, send a copy of Attachment 1 to [email protected]. 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 [email protected]. 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
- 11 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.
- Product codes and lots
- Lot Numbers: UDI Number 630770 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304448490(17)211228(10)630770 646170 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304448490(17)211227(10)646170 530980 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM (01)00880304556140(17)211228(10)530980 570570 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM (01)00880304448605(17)220106(10)570570 477430 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM (01)00880304493131(17)220115(10)477430 505490 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM (01)00880304556119(17)220115(10)505490
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2144-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2145-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2146-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2147-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2148-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2149-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2150-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2151-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2152-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2153-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2154-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2155-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2156-2020 | Class II | Terminated | Voluntary: Firm initiated |
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