Z-2149-2020Class II
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee...
Zimmer GmbH / initiated 2020-04-17 / Terminated / root cause: manufacturing process
Biomet, Inc. began a recall of Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM... 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-2149-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM 155346 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155328 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM 155388 Knees AGC Knee System PS Molded Tibial component, 18 MM X 85 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
- 54 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 570460 AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM (01)00880304000865(17)220111(10)570460 515880 AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM (01)00880304000193(17)220106(10)515880 602810 AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM (01)00880304246034(17)220105(10)602810 494090 AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM (01)00880304003781(17)220106(10)494090 505320 AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM (01)00880304246096(17)220106(10)505320 578470 AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM (01)00880304000193(17)220114(10)578470 447820 AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM (01)00880304000179(17)220118(10)447820 494030 AGC Knee System PS Molded Tibial component, 18 MM X 85 MM (01)00880304246256(17)220118(10)494030
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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