Biomet: Medical Device Recall in 2020 - (Recall #: Z-2318-2020)

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:

A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.

Product Classification:

Class II

Date Initiated: May 14, 2020

Date Posted: June 17, 2020

Recall Number: Z-2318-2020

Event ID: 85701

Reason for Recall:

Distributed to the field without having completed design history files or design transfer activities

Status: Terminated

Product Quantity: 1 US and 1 OUS

Code Information:

Lot Number: 356280 (01)00887868134838(17)270716(10)356280; RM256H (01)00887868134838(17)260304(10)RM256H

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.

Voluntary or Mandated:

Voluntary: Firm initiated