Z-2156-2020 Class II Terminated
FDA device recall Z-2156-2020 was initiated by Biomet, Inc. on April 17, 2020 and is designated Class II. Reason for recall: Potential presence of elevated endotoxin levels that exceed the specification limit The recall status is terminated (terminated June 25, 2021). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- April 17, 2020
- Termination Date
- June 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis
Reason for Recall
Potential presence of elevated endotoxin levels that exceed the specification limit
Distribution Pattern
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.
Code Information
Lot Number/UDI: 735550 (01)00841036226534(17)220111(10)735550