Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2144-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.

Product Classification:

Class II

Date Initiated: April 17, 2020

Date Posted: June 3, 2020

Recall Number: Z-2144-2020

Event ID: 85524

Reason for Recall:

Potential presence of elevated endotoxin levels that exceed the specification limit

Status: Terminated

Product Quantity: 122 units

Code Information:

Lot Numbers: 1)597000 UDI (01)00880304462489(17)211229(10)597000 2) 502510 UDI (01)00880304475458(17)211229(10)502510 3) 744880 UDI (01)00880304475434(17)220117(10)744880

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.

Voluntary or Mandated:

Voluntary: Firm initiated