Device product

Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis

Z-2156-2020

April 17, 2020

Class II

Product summary

Firm: Biomet, Inc.
Event: Event 85524
Status: Terminated
Classification: Class II
Quantity: 1
Official record key: device-enforcement:Z-2156-2020

Official wording

Reason: Potential presence of elevated endotoxin levels that exceed the specification limit

Code information: Lot Number/UDI: 735550 (01)00841036226534(17)220111(10)735550

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential presence of elevated endotoxin levels that exceed the specification limit