Device product

Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis

Z-2146-2020

April 17, 2020

Class II

Product summary

Firm: Biomet, Inc.
Event: Event 85524
Status: Terminated
Classification: Class II
Quantity: 15 units
Official record key: device-enforcement:Z-2146-2020

Official wording

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

Code information: Lot Numbers: UDI Number 1) 561760 (01)00880304554412(17)211229(10)561760; 2) 091090 (01)00880304506084(17)211214(10)091090

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